Just too good to be true

Steven Koepke, who goes by koepkesd @ Stocktwits and Steven @ Yahoo, has been busy reading this blog while trying to justify the lies by the Nanox CEO that somehow the $200 (or $100, depending on the day) Nanox.Tube can replace the $150,000 modern CT tube (these are "list prices," of course).

For the longest time I was trying to figure out how Ran can claim that his field emitting device (FED) can generate x-rays on par with the high end x-ray tubes used in CT machines. Those large tubes can generate 800 to 1,000 mA at 120 kV. They also cost $120,000-$150,000. Here is the math. The MEMS (FED) chip has an active area of 0.126cm^2 (4mm diameter on chip in diameter and the power level was communicated at 2.5A/cm^2. The power is concentrated down via focusing device onto the tungsten anode. The basic math provides the power of the beam to be 314mA and 120 kV (per conference call last week). That's quite close and running multiple sources in parallel amplifies the power. Cost comparison: 5 small tubes @ $100 vs $150,000 for singe large CT device tube. Micro-X has a similar arrangement working today with a CNT device (also Field Emitting Device)

 

So, what's wrong with his reasoning?

There is no such thing as a field emitting device.  FED refers to a failed display technology -  a field emitting DISPLAY.  It does not contain "a field" of emitters, as Nanox CEO believes - it emits electrons induced by an electrostatic field.  It is not a more efficient or a cooler way to generate x-rays - all x-ray tubes, whether using a cold cathode (based on the field effect) or a hot cathode (using a hot filament) to emit electrons, have about 1% efficiency as 99% of the energy applied to the tube gets wasted as heat at the anode.  A hot filament uses a lower voltage - about 4V - than the 40V (or way more) needed by a cold cathode.  Roentgen discovered x-rays in 1895 using a cold-cathode (gas discharge) tube.  GE invented the hot-cathode x-ray tube in 1913 and obliterated the cold-cathode ones.

The proposed Nanox.Source chip is not MEMS, as there is nothing mechanical about it.  The chip is not real, or commercially available, of course, as Nanox has no ability to manufacture it commercially, at least not yet.

The current density of 2.5A/cm^2 comes from a fraudulent, that is, intentionally misleading, 2015 datasheet by Nanox predecessor, which I have previously linked here on this blog. 

The Nanox.Tube cannot do 314mA and 120 kVp.  The one used in the Nanox.Cart can do up to 2mA and up to 40 kVp, at most (or 0.08 kW, per 510K summary).  The CEI one can do up to 1mA and up to 100 kVp (or something like 0.1 kW, per CEI video).  The tube used by GE in the predicate device for Nanox.Cart can do about 40 kW - it has a rotating anode.  The CT tube can do about 120 kW (using Steven's numbers). So, to replicate the power of a $150,000 CT tube, one needs to use, oh, something like 1,000-1,500 Nanox tubes that cost $100,000 or more.  An after-market CT tube will cost less than $100,000, of course.  All this has been already discussed last year.

Micro-X has a 4.8 kW tube (a bulky stationary-anode one) - it uses carbon nanotubes, which Nanox says is impossible - it sells a few units a year.  The biggest CEI tubes are smaller sizes than Micro-X's and go up to about 2.5 kW (also stationary-anode ones).  

Update June 10, 2021:  Investors will eventually blame Nanox CEO for their delusions.  Steven continues:

The anode temperature becomes the challenge with the NNOX tube. CEI states that their tubes can handle about 60KJ. The RSNA video shows the bed is moving through the sources quickly (15-20 seconds for whole body). My guess is that NNOX is using high current short bursts to keep the anode temperature under control. In the video they may have used 300mA for up to 0.2 seconds to make 10 shots (capturing 8" per shot) while the cart moves through. 300mA x 0.2 X 10 shots = 60KJ. You can't shot this with dental tubes like that. They don't have the current and the image gets too blurry.

He is right that a typical dental tube (which has a better performance than the Nanox tube) cannot do 300mA.  He is also right that at some point, the heat capacity of the anode becomes a challenge (the anode temperature is not really a problem - it is the temperature of a part of the anode, the tungsten target, that is the challenge).

But Steven does not understand what heat capacity means.  Yes, one of CEI's most powerful medical tubes, OX125-06, can handle 60 kJ (CEI only makes stationary-anode tubes).  But that does not mean that it can do 300 mA or that 300 mA  x 0.2 s  x 100 kVp  x 10 shots = 60 kJ.  Nor does it mean that you can do 5 A x 0.2 s  x 60 kVp x 1 shot.  CEI provides nice charts in its datasheets to explain the interplay between heat capacity, tube current, tube voltage, and time.

As the charts show, the tube cannot do more than 35mA at 60kVp for 0.1s or more than 20mA at 110 kVp for 0.1s. But it can do 15 mA at 100 kVp for 10 seconds.  The RSNS 2020 demo, which we now know was fake, never demonstrated a full-body scan - it scanned three phantom "organs." The "hand" scan consisted of 45 "shots" or images ( 5 tubes x 9 tilts/translations) - it took about 50 seconds for the images thumbnails to appear on the display.  That is about 1 second per shot, not 0.2 seconds (and we don't know what that's even real).

The CEI OX-70, a dental tube,  can do about 32mA at 60 kVp for 0.1s or more than 20mA at 90 kVp for 0.1s.  It can do 10mA at 90 kVp for 10 seconds.  Here is some summary table from CEI's datasheets.  Stationary-anode tubes all look kind of the same.  The tubes that do less than 100 kVp are "dental" and typically tolerate half the current than the "medical," and are a bit smaller. 

Model	Voltage  kVp	Current mA, 0.1s	Current mA, 100kV	Focal sp. (mm)	Diam. (mm)	Length (mm)
Small/Dental tubes
OX/70-P	70	19	N/A	0.8	30	72
OX/70-5	70	11	N/A	0.5	30	72
OCX/65-G	70	12	N/A	0.8	30	76
OX/70-4	70	9	N/A	0.4	30	72
OX/70	90	21	N/A	1.2	30	82
OX/90	90	9	N/A	0.5	30	83
OCX/70-G	70	12	N/A	0.8	30	65
OCX/70-G4	70	8	N/A	0.4	30	65
Medical/Mobile tubes
OPX/105	110	18	2.5	0.5	42	125
OPX/105-4	105	17	2.5	0.4	42	95
3D/cone-beam CT tubes
OCX/100	105	20	4	0.5	46	140
OX/100	100	26	1.5	1.0	35	85

Recall, the Nanox tube in Nanox.Cart can do only 2mA at 40 kVp (for 0.1s -1 s).  The CEI Nanox tube can do only 1 mA at 100 kVp for 40 seconds (per CEI video).  The CEI OX-70 dental tube can do about 40 mA at 40 kVp for 0.1s, about 25 mA at 40 kVp for 1s, and about 3 mA at 90 kVp for about 40 seconds (per datasheet charts).  If Nanox tubes perform like poorly-made hot-cathode dental tubes, they probably are.  No mystery Nanox.Source chip required.

Update June 10, 2021:   Just to clarify, regular dental tubes (just one or 5 ) can definitely replicate the fake RSNA 2020 Nanox.Arc demo.  The "hand" scan took about 50 seconds for 45 images.  Let's see whether a dental tube can do 45 images at 45 seconds, that is, a bit faster.  A CEI dental tube operating at 90 kVp can do 3mA continuously for 45 seconds, so each exposure (image) will be 3 mAs at 90 kVp.  The Nanox.Cart demo at RSNA 2020 image needed just 1.5 mAs at 40 kVp (so, significantly less than 1/4 of what the CEI dental tube can supply).  Commercial fluoroscopy equipment does ok with 100 kVp and 1 mAs for each frame (image) at 30 fps.  So, sure, with a good enough (expensive enough) detector, you can do the Nanox.Arc tomosynthesis within 45 seconds.  But the detector (regardless of the tubes used) won't cost anywhere near $10,000.  And no one would like to look at the images (the American College of Radiology never considers a tomosynthesis procedure to be "usually appropriate,"  except for breast, which the Arc cannot do).

When your own supplier exposes you as a fraud

At the Berengerg investor presentation today, Nanox CEO confirmed for the first time the name of its new supplier, CEI (Slide 17).

The problem is that CEI has a public website.  There we learn that the company's average production was 18/22,000 tubes/year and the revenue (turnover) in year 2007 was 3.4 million euros (things went downhill since).  So what exactly is the problem?  Well, the average price of CEI's legacy x-ray tubes, using those numbers above, comes to about EUR170 a piece (that's about $230 a piece at 2007 exchange rate).

But Slide 16 in the investor presentation had just stated that legacy x-ray tubes sell for $150,000 (that's almost three orders of magnitude discrepancy!).

And based on video leaked by Nanox, the Nanox tube that CEI is supposedly almost ready to make is a bit larger, not smaller than the legacy tubes that CEI makes.

Ooops!  Looks like CEI exposed Nanox as a fraud.

Now, yes, it is true that some x-ray tubes do indeed cost $150,000 or more.  But those tubes have nothing to do with the tubes that CEI is supposedly about to make for Nanox (as their power and performance is three orders of magnitude higher, too). 

 

Summary notes

The Summary of the 510(k) submission by Nanox for its Nanox.Cart device was published last week.  Here are some observations, in no particular order of importance (yet).

The name of the predicate device is wrong

The name of the predicate device, cleared under K021016, is AMX-4 Plus Mobile X-Ray System, not AMX-4 Mobile X-Ray System as claimed by the Summary.  What else is incorrect, if Nanox cannot even get the name of the predicate device right?  The "Plus" system is the upgraded model.  The predicate of the Plus model is AMX-3 Mobile X-ray System, K802047, another GE system.  The chair of Nanox Advisory Board is a former GE executive.

A micro-controller Arduino Mega 256 does not exist

Table 1 claims that Nanox.Cart uses a micro-controller Arduino Mega 256 that "controls the Nanox Cart X-ray System's functionality and GUI display."   No such micro-controller exists.  There is an Arduino Mega 2560 micro-controller board designed for hobbyists that uses the old and cheap ATmega2560 micro-controller released more than 15 years ago.  Quite novel.

The target angle of 0 degrees in Table 1 is non-sensical (a typo) and contradicts the 16 degrees value in Table 2

The target, or anode, angle is a very important characteristic of an x-ray tube, as it determines focal size and beam width, strength and composition.  At zero degrees, the tube will be completely unusable.  It is one mistake that Nanox should not have made, if its "X-ray source technology [were] the basis of [its] business" (page 9, annual report).

The maximum tube voltage for the predicate device in Table 1 is incorrect

Table 1 claims that the maximum tube voltage for the predicate device is 100 kV, which clearly contradicts the 125 kV value from the "kV range" section in the same table.  The actual value is 130 kV (from the tech specs of the HRT09 tube).

The power output of the reference device is annoying

Table 2 states that the power output of the reference device is 4.8 kW @ 104 msec, which is incorrect (a typo) and it should be "@100 msec," which is the standard (for example, IEC 60613:2010). 

The x-ray source used by Nanox.Cart is still a mystery

There is no mention in the summary of any of the non-sensical descriptions that Nanox typically uses for its proposed x-ray source - digital, MEMs, silicon, semi-conductor, novel, etc.   Table 2 claims that the "Nanox Tube" is similar to "Xinray CNT Tube," but that is incorrect based on the data in Table 2, as the CNT tube is 60x as powerful (4.8kW vs 0.08kW), capable of substantially higher tube voltage (110kVp vs 40kVp) and current.  Table 1 mentions that Nanox.Cart uses a "Nano-x's Cold Cathode tube" in the system description, but the tube type/model in both Table 1 and 2 is given as "Nanox Tube" (no cold-cathode here) and there is no tube model (Nanox' web site shows at least 4 completely different and incompatible "Nanox tubes" that look remarkably similar to regular industrial/dental hot-cathode tubes).

The mention of an x-ray source in the intended use is non-sensical

The description of the device's intended use begins with the non-sensical statement

The product is intended as an X-Ray source for diagnosis. 

The product is a mobile x-ray system - FDA product code IZL - not a x-ray source (which almost exclusively means an x-ray tube in the context of modern diagnostic equipment - other sources could be radioactive isotopes, synchrotrons, etc).  The product is supposed to include many more components other than an x-ray tube, as confirmed by the "system components" section in  Table 1, for example,  It appears this statement was intentionally inserted by Nanox to confuse investors and possibly subvert the 510(k) clearance process.

The single-source Nanox device is cleared only for hands, wrists, and fingers, on adult patients only

Both Table 1 and Table 2 claim that the intended use of the device is similar to that of the predicate and reference devices.  But that is incorrect and contradicts the actual description of the intended use, as the device is cleared for a very limited subset of examinations, while both the predicate and reference devices can do all general purpose X-ray diagnostic procedures.  In fact, the limitation for use explicitly states:

This device is not intended for general radiographic X-Ray examinations other than the indicated use...

So much for Nanox curing cancer.

The Nanox device is cleared to work with only one detector model, which appears unsuitable and has to be purchased separately

There is a bit of problem with the tech specs of the detector that Nanox has chosen to work with its device.  The summary states:

The Nanox Cart is specified and designed to operate only with a Flat Panel Digital X-ray Detector Model EVS3643, manufactured by DRTECH Inc.

The summary of the detector clearance specifies that the X-ray system using it must have tube voltage equal or higher to 40 kVp, so Nanox.Cart barely complies (its tube voltage is fixed at 40 kVp per Table 1 and 2). What is more troubling is that the generator "mA Range" used in the detector clearance is specified as "10mA ~ 1000mA," which Nanox Cart fails to meet, as it cannot deliver more than 2mA (implied by 0.08 kW power output and 40 kVp tube voltage).  

More importantly, this detector cannot be used for diagnostic purposes on a live subject by the proposed multi-source Nanox.Arc device, as it is too slow and takes about 5 seconds to capture and transfer an image.  A 45-image tomosynthesis of a wrist, for example, would take at least 4 minutes, if the RSNA 2020 demo were anywhere close to reality.

Finally, the lowest quote for this detector, obtained in the gray market - new, but from unauthorized distributors and without warranty - is about $20,000.  So much for being "cheap."

Many of the images supposedly made with the single-source device in the annual report and in investor presentations are likely fake

According to the annual report, 

[Nanox has] generated the images below with the Nanox.ARC using a single X-ray tube on an imaging phantom (page 61).

 

However, none of these images were generated by the device that received clearance, as the device tube voltage is limited to 40 kVp (so the 50 kVp tube voltage in the images is impossible).  Moreover, the device is not cleared for ankle/foot examinations.

Here is another image, from Nanox investor presentations, that is impossible to create by the device that got cleared.  

First, the device is not cleared for shoulder examinations.  Second, the 2.5mA reading exceeds the maximum device tube current of 2mA.

The mobility of the device is questionable

The device is cleared under the IZL product code, but it is not truly mobile/transportable.  The device description states:

The system facilitates X-ray examinations in situations where it is not possible or feasible to transport the patient to a ward with fixed equipment

But the device has no battery, unlike its predicate - it is as mobile as the length of the cord (less mobile than a regular vacuum cleaner). 

The device is "similar" to the predicate device, except that it is not

The section "Substantial Equivalence Discussion" is somewhat confusing.  The section argues that the device is equivalent except that it is not. 

The technical characteristics of the System are not different from the predicate device except for the fixed Source-to-image Distance, Field of view, aperture, focal spot size, and the fixed tube voltage and reduced maximum exposure current-time product. 

Virtually all technical characteristics of the two devices are significantly different, and, it can be argued, raise many questions of effectiveness.  Table 1, for example, confusingly states that the fixed tube voltage and current exposure time product (or charge) are similar to the significantly wider ranges that are needed in practice and can be obtained from the predicate device.  For example, typical "technique charts" for digital detectors stipulate tube voltages of least 46 kVp for the intended use (adult fingers/wrist/hands), above the 40 kVp limit of the device.

The device requires cooling fluid

This must be surprising to Nanox investors who are led to believe by the CEO that a cold-cathode tube, even if real, runs somehow cooler than a regular hot-cathode tube of the same power.

The intended use contradicts the disclosures in the SEC filings

Nanox implies in its SEC filings that the device will not be commercialized, and so the statement that the indented use is to perform diagnostic radiographic examinations is misleading.

Specifically,  Nanox states in its SEC filings:

the multiple-source Nanox.ARC [rather than this cleared Nanox.Cart device] ... will be our commercial imaging system (page 2, Prospectus). 

Nanox has further revealed that, while not intending commercial distribution of the cleared device, it is using the 510(k) submission as part of its regulatory strategy, a step in 

a multi-step approach to the regulatory clearance process (page 1, Prospectus), 

where the apparent ultimate goal is to induce the FDA to clear the "the multiple-source Nanox.ARC" device by first creating a predicate out of the Nanox.Cart.

Therefore, any statements by Nanox about "indications for use" or intended use or intent to market the cleared device, other than an admission that the device is not intended to be marketed and the submission is simply a step in Nanox regulatory strategy, are problematic.

Update:  Here is a cheap (dental) tube, Toshiba/Canon D-081B, that is used in other devices cleared under the IZL  product code, that is smaller but much more powerful and much more useful than the proposed "Nanox Tube."

Update:  Replaced "implied by 2mAs and 1 second" with "implied by 0.08kW power output and 40 kVp tube voltage" as it is the correct derivation for max tube current (sustained for 0.1s) - in this case, both derivations result in 2mA tube current.

Update:  Nanox predecessor claimed in 2016 that the chip that forms its cold cathode can do 2.5A/cm2 (Nanox CEO was a Chief Strategy Officer at the time).  If Nanox had made no improvements since, it means that the active area of its "chip" is now 0.0008 cm2 or a square of about 0.3 mm x 0.3mm.  So why do the chips shown in Nanox annual report (page 66) and in a March 2021 tweet look much larger, at least 10 mm x 10 mm?  Each covering an area that is at least 1000x the supposed area claimed in 2016 ...

 

Of course, as discussed elsewhere on this blog, Nanox has been unable to manufacture such a chip commercially (and so the proposed Nanox Tube is almost certainly not using any chip or any cold cathode), contrary to claims in its annual report (the University of Tokyo labs, which Nanox claims to rent, prohibit commercial use).

Update May 11, 2021:  Replaced the image of the wafer from the annual report with an image from a tweet that shows the chip next to a ruler.   

Update May 14,2021: Garage Blitz TV @Youtube makes a great point about the reference device using a CNT tube, which according to the Nanox annual report cannot work.  Moreover, the Nanox "founder" claimed in November 2019 that no such device exists, to the best of Nanox "knowledge."  

The curious case of Nanox.Arc's development

Last week @Ehlyz on Yahoo linked to a webpage of the engineering firm Ziv-Av and wrote:

If you are still worried this company is fraud and there is no end product to sell, take a look at who is building their CT scanner, Ziv-Av, who is also a vendor for Mazor Robotics and other medical companies.

Sure enough, the engineering firm Ziv-Av claims that the Nanox.Arc device was developed by Ziv-Av's engineers, not by Nanox (Nanox supposedly only contributed a proposed x-ray source).

According to the webpage, published sometime in 2020 prior to Nanox IPO, Nanox.Arc is a revolutionary x-ray device that could do anything the current technology could, but it is smaller, more mobile, and at least 1/100 as affordable.  The device was developed in record time - just 3 months, from scratch and for peanuts (Nanox shows in its prospectus on page 9 less than $3 million in research and development expenses for the entire 2019).  It was this working prototype that supposedly led to the equity raise and Foxconn "endorsement" in January 2020.

The problem is that that the device shown on the webpage (Nanox.Arc version 1.0, according to Nanox tech webpage) is completely fake.  It cannot take any x-ray images because it does not have any x-ray tubes and any x-ray detectors.  It only has a battery and blue LED lights - no need for the special cooling system that Ziv-Av claims to have developed.   

Ziv-Av's claim that this was a "working" prototype also contradicts the draft registration statement that Nanox did not have a working prototype prior to February 2020 (that is, the equity raise in January 2020 must have occurred without a working prototype):

We have not produced a working prototype of the Nanox.Arc (page 9) 

Moreover, if the working prototype looked like what Ziv-Av is showing, then the device in the demo to Foxconn in December 2019 shown below must have used a non-working prototype - that is, the demo was fake.

device demoed to Foxconn, December 2019

Here is the list of all the false and weird claims by Ziv-Av on that webpage:

1.  Ziv-Av develops revolutionary and affordable CT scanner for Nanox

Nope, even if the device were not fake, it cannot be used as a CT scanner due to limited number of projections (a CT scan uses hundreds of projections at different angles per arc/rotation).  It is affordable only because it is completely fake. 

2.  Nanox is a medical imaging company which has developed a revolutionary CT device that is mobile, substantially smaller and extremely cheaper than the existing devices. 

Nanox now denies that its proposed concept device is a CT device, and says it is a tomosynthesis device (unable to generate axial slices).  The device is cheap only because it is fake - the main cost of a real device would be in the detector.

3.  Nanox’s CT technology is based on digital X-ray production using a MEMS component instead of conventional flame lamps enabling cost reduction by orders of magnitude. 

There is no such thing as digital x-ray production - the proposed Nanox x-ray source generates x-rays the same way as a regular $100 hot-cathode x-ray tube - by smashing a bunch of electrons into a metal target.  And the cost of a Nanox tube will always be higher than a regular x-ray tube of the same performance, as any non-defective chip will cost more to make than a filament (a piece of wire).  It is also apparent that Ziv-Av believes x-rays are generated by conventional flame lamps - not clear whether burning kerosene or lamp oil.

conventional x-ray tube per Ziv-Av ( image source: https://www.freeimages.com/photo/the-oil-lamp-3-1535516 )

4.  The device supports scans such as CT, mammography, fluoroscopy and angiography.

Nanox now denies the CT and mammography "support" (CT-like imagining with 11 sources is now a simulation only).  Fluoroscopy and angiography are still on the table for the concept device, but they would be extremely limited, as its device lacks the positional flexibility of modern low-cost C-arm devices.

5.  Ziv-Av engineers revolutionized the medical imaging system 

Nope - the medical imaging system is still the same.

6.  Nanox approached Ziv-Av for the design of the revolutionary digital X-ray machine and its prototype within a stringent timeline of three months.

This may actually be true.  But the only revolutionary thing was the complete fakeness of the device. 

7.  Among many other design features, Ziv-Av designed the arch of the scanner which scans the patient’s body from different angles. 

Oh, so the Arc idea came from Ziv-Av rather than Nanox...

8.  The arch is designed to work with a very high voltage of 70,000V which creates immense heat. 

The statement that 70kV is associated with immense heat shows that Ziv-Av engineers do not understand basic physics and engineering.  An x-ray tube that operates at 1mA generates less heat than a 100W lightbulb.  Also, 70kV tube voltage is too low for a general x-ray device (it could be ok for extremities). 

this lightbulb generates immense heat per Ziv-Av (image source: https://www.freeimages.com/photo/light-bulb-1531205 ) 

9.  Ziv-Av managed the heat dissipation by designing a cooling system. 

The cooling system in the device is fake and not needed, as there is no x-ray source.  Subsequent proposed device iterations by Nanox show that the proposed "cooling system" is just a CNC-cut metal slab - a simple, and not very effective, heat sink.

 

10.  Along with the arch of this amazing machine, Ziv-Av also provided the design of the machine’s table, mechanics, electricity, electronics and motion control system .

Wow - so the only thing that Nanox has developed was the proposed x-ray source, and everything else (fake, of course) came from Ziv-Av? 

11.  Through its specialists, Ziv-Av achieved a significant cost-reduction – realizing Nanox’ vision of affordability to all.

True.  A fake device without an x-ray source or a detector or even a high-voltage generator would be cheap and affordable, indeed.  And, as a plus, it does not even require radiation shielding.  The only downside - it can generate no images.

12.  Ziv-Av excels in cost-effective prototype production.  Ziv-Av’s multidisciplinary engineers provided a turnkey solution from design to production of this innovative machine. 

It is innovative and cost-effective, as it is completely fake - a rarity!

12.  All the production, assembly & integration and tests were performed in Ziv-Av’s well-equipped workshop. 

No doubt.  Again, Nanox only contributed a proposed (fake) x-ray source.  

13.  The demonstrations of this perfectly working prototype helped Nanox raise $26 million within three months from many investors including ‘Foxconn-the IT industry giant’. 

By perfectly working, Ziv-Av means it can light up in blue using the built-in LEDs and a 12V battery, of course.

14.  From scratch to a revolutionary, cost-effective design as well as a working prototype – Ziv-Av accomplished all in just 3 months.

Nice.

What the webpage does not say is that the engineering firm's owner, Mr. Ziv-Av, at some point a chief scientist of the Israeli Ministry of Transportation, was convicted of securities fraud and then claimed that he did not know what he was doing.

Update:  Apparently, a Nanox promoter also tweeted about Ziv-Av last week, transforming CT or computed tomography into "3d tomo" (tomo simply means slice in greek), falsely claiming that a single (non-axial) slice meant CT-like capability, and insisting 70kV or less is not a problem for chest:

Chest/lung, musculoskeletal including skull likely on this 510(k) w/ enhanced 3D, slices, plus 2D x-ray. Cheap device. Will expand market.

Yeah, will expand the market with a completely fake device.

Update December 20, 2021:  Minor spelling correction.  

Lost in translation

According to a recent Google-translated Korean article about the planned fab, or factory, Nanox plans to make only 2,000 x-ray tubes a month.  

The investment is about 40 million dollars... Nanox plans to produce about 2,000 semiconductor chips and tubes per month for digital X-rays at [the planned Korean] factory. (google translated)

Something must be wrong with the translation by Google.  Making only 2,000 tubes a month means that the cost can never get to $100 a piece, a cost that would be competitive with regular Chinese tubes of equivalent power/performance.

from Slide 15, January 2020 investor presentation  

Here is the simple math:  Recouping just the capital investment at a $100 cost would require making 400,000 non-defective tubes, which would take over 16 years (given the supposed plan for 24,000 tubes a year ).  So, a $100 Nanox tube would not be possible with this fab, if the translated article is correct.

In an interview in September 2020, the CEO told a different story about that same planned fab:

We are shooting for quite a large capacity because we think that Nanox eventually will be in many, many devices, so we are planning for about 1,000 wafers per month (about 5:30 into the video).

Depending on the wafer size and layout, a real company making real MEMS chips of similar size, should get from less than 100 to nearly 200 chips per wafer, or about 40-100 non-defective chips per wafer (assuming yield of 40% and over).

Nanox wafers, annual report, page 66 

But what is Nanox going to do with over one million non-defective chips a year (or over three million by end of 2024)?  All the planned 15,000 Nanox.Arc devices by end of 2024 need only 75,000 to 165,000 tubes in total (depending on whether 5 or 11 tubes per proposed device).  There are only about "500,000 plus" x-ray imaging systems in the world (page 11, Varex filing)

CT vs Tomo vs Fluoro

I have been having some interesting discussion with Nuno Lemos aka StockZombie @ Twitter, who has compiled his due diligence on Nanox at "Nanox Vision – a fools gold?"  

Here is some feedback on some of his points. 

Can you replicate CT with Tomo?

Nanox has been misleading the public, investors, and medical professionals for quite some time that it can do CT (including the "noise-free simulation" slide shown on the TV screen near the end of the RSNA 2020 presentation, 24:04).

That simulation was supposedly done with an imaginary device with 11 sources and detectors that don't exist.

But Nanox admits in its Prospectus that it intends to do only tomosynthesis - no usable axial slices can be produced.  CT or CAT is a short-cut for Computed Axial Tomography.  See also below.

Does the proposed Nanox.Arc 2.0 have 5 or 6 x-ray sources?

The information about the 5 x-ray sources comes from a video showing the making of Nanox.Arc 2.0.  If one pays close attention at 0:19-0:20, one can see the holes of the 5 sources.  I tweeted about it and so did Nanox promoter, but he did not count the holes.  

counted by me

not counted by promoter

The CEO was lying throughout the RSNA 2020 presentation that the device had 6 x-ray sources.  If the sources were so precious and novel, he would have gotten a least the number correct, as this was the first public demo of the source.

Here is how Nanox advertised its presentation on its exhibitor page at RSNA 2020:

Nano-X Imaging Ltd Nanox is a developer of MEMs based electrons field emitter cold-cathode, enabling the manufacturing of digitally controlled, low-cost x-ray tubes. Nanox's technology is under third party review, pending 510k clearance. Please join the Virtual Meeting Room button below at 10:30 am CST on Thursday, December 3 for a Featured Demonstration as Nanox unveils a proprietary digital X-ray source based on a silicon MEMs electrons field-emission technology. The presentation debuts a novel X-ray tube that emits digitally controlled X-ray pulses and can be used across multiple medical imaging use cases. https://www.nanox.vision 

So, what is the main proposed modality of Nanox.Arc 2.0?

Page 1 of the Prospectus explains that the main use of the Nanox.Arc that Nanox supposedly plans to commercialize is tomosynthesis:

Subject to receiving regulatory clearance, the first version of the Nanox.ARC that we expect to introduce to the market will be a three-dimensional (“3D”) tomosynthesis imaging system. Tomosynthesis is an imaging technique widely used for early detection, that is designed to produce a high-resolution, 3D X-ray image reconstruction of the scanned human body part for review by a professional diagnostics expert

Slide 8 from the March 17, 2021 Oppenheimer presentation states: 

The Nanox.ARC 3D computerized tomosynthesis:  New breed of medical imaging.  

Also, if one looks carefully during the RSNA 2020 presentation video (for example, at 12:55), what Nanox appears to be doing for any "scan" is collecting 45 images (5 sources x 9 tilted positions) and creating synthetic slices from them in a plane parallel to the flat detector placed in the "box" below the arc.

Can the proposed Nanox.Arc, either single-source or 2.0, do fluoro?

According to Nanox, Nanox.Arc can do fluoroscopy (even though it is not its main use case), but Nanox can also license its proposed x-ray source to traditional device manufacturers to incorporate in their own fluoroscopy systems (the white paper addresses that second case).  Today's fluoroscopy systems are very simple - a single source (pulsed, for two reasons - to prevent source overheating, and to reduce radiation exposure) and a fast detector (10+ fps) - clearly a single-source Nanox.Arc can do it (for say, $200,000/unit) ,assuming a powerful enough hot-cathode dental source with a stationary anode (but the best price quote for a new system I have gotten is $28,500/unit FOB Shanghai, and it is not cleared yet in the USA, so it cannot be used as a predicate).  

Slide 20 of the January 2020 presentation at JP Morgan shows the multi-source Nanox.Arc device doing "3D fluoroscopy" (I guess you need a Hololens or Oculus headset for it) using 3 of the 5 sources. 

Yes, fluoroscopy has its own product code(s) for 510K clearance purposes (for example, JAA), but a system can have more than one product code for clearance purposes.

Update:  Here is the completely-misleading slide from the January 2021 JP Morgan presentation that shows that the proposed Nanox.Arc 2.0 can replace the Chinese fluoroscopy system, among others.  See also my previous post, focusing on cost.

Foolish misdirection

Nanox stock is up more than 15% today.  The catalyst may have been a nice promo that claims that Nanox, the healthcare disrupter, is about to receive FDA clearance within a month and start distributing its new X-ray device.

Quite interesting, given that Nanox claims that it has not submitted its magic device for FDA clearance yet.  Nanox claims instead that it has submitted another, a "single-source," device that it does not intend to market or ship or distribute or offer for subscription or service.    

Here are some of the factual inaccuracies and false implications in the promo:

• Nanox has a new kind of X-ray
• X-rays are kind of boring
• [X-ray devices] are very expensive
• MRI devices use or create X-rays
• A CT scanner costs about a million, 2 million, 3 million dollars
• Nanox has made a radical new discovery
• The traditional X-ray devices and CT scanners create X-rays by heating the machine up over 1,000 degrees Fahrenheit, might be 2,000 degrees Fahrenheit
• X-rays devices and CT scanners are incredibly hot machines and have to be cooled down
• The expense in X-rays devices and CT scanners is in cooling the devices down
• Nanox can create X-rays without having to manufacture all this heat and cool the machine down
• Nanox proposed machine is far cheaper (to manufacture), $10,000 instead of a $1,000,000
• Nanox will radically disrupt the market, and is also going to expand the market
• We are going to see a lot more X-rays
• The proposed Nanox machine (a rudimentary tomosynthesis device) can generate images that are comparable to MRI images or CT images, not just to traditional X-ray or tomosynthesis images.

Update (March 13/14, 2021):    thedudemd  @ Stocktwits disagrees that the factual inaccuracies are factual inaccuracies and argues that 

a)  "Traditional xray tubes used in cts do get incredibly hot; so much so that scanners automatically shut down if tube gets overheated,"  and   

b)  "ct scanners do cost millions of dollars."

Tubes or devices/machines?  The Fool contributor said that the traditional x-ray device or traditional CT scanner was being heated up over 1,000 degrees Fahrenheit, which is clearly not true.  These systems operate at room temperature.

But let's talk tubes.  Both the traditional and the proposed Nanox tubes use the exact same inefficient mechanism of generating x-rays, whereby nearly 99% of the heat is generated at the anode and nearly 99% of the energy used to generate x-rays gets wasted as heat.

Interestingly, the filament in the tiny incandescent Christmas tree lightbulb gets even hotter - 2,200 degrees Kelvin to 3,200 degrees Kelvin -  or 3,500 degrees Fahrenheit to 5,300 degrees Fahrenheit!  Each one filament operates at about 2.5 V consuming about 0.4 W, and there are hundreds of them on the tree.  Christmas trees must get incredibly hot and burn up instantly, no?

  

Photo by Jason  Krieger from FreeImages.com

Regarding costs - maybe the latest and greatest CT scanner could cost over $2 million, but you can buy a used one for $80,000, as described here and here.   Of course, the proposed fake five-source Nanox.Arc is in no way comparable to even the oldest, cheapest and abused CT, as it cannot generate axial slices, even in theory.  Moreover, it is not even submitted for clearance, according to Nanox.  The device that Nanox claims to have submitted for clearance is a single-source device that cannot be cleared.

Update June 3, 2021:  The Nanox single-source device that got cleared was the Nanox.Cart.

Why Nanox.Arc has no chance for clearance

Nanox has a nice video on its front webpage titled "Understanding Nanox technology & vision"  It is extremely misleading, and, thus, extremely useful to regulators.  It proves that Nanox.Arc has no chance for FDA clearance, not this year and not ever.

How so?  Well, about 40 seconds into the video, the mesmerizing voice proclaims:

Years of dedicated development by Japanese and Israeli scientists have achieved a novel X-ray source and device that bring hope by being more affordable by orders of magnitude than the conventional X-ray technology used today.

Oops.  See, the FDA clearance pathway is only for a device that is substantially equivalent to a legally marketed device.  A novel device will be immediately rejected, as it fails the RTA checklist, and must go through either a De Novo classification request or a PMA approval submission.  Either one takes years.

Incidentally, according to the same segment in the video, the device below represents the X-ray technology used today:

Unfortunately, that is a sketch of an MRI device, which has nothing to do with X-ray technology - note the "chimney," which is actually part of liquid-helium cooling system (the superconducting electromagnets require very low temperature to operate).

Thanks to ThreadEnhancer @ AuntMinnie for the novel tip.

The video was published sometime in February or March, 2020, that is, after the supposed January 2020 submission for clearance of the single-source device.

Update:  The MRI device in the sketch is a stylized Siemens MAGNETOM.

Update (March 13, 2021):  The video, of course, is not the only place where Nanox explicitly describes Nanox.Arc as novel.

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device).  Nanox.Arc (a multi-source one) still has no chance of clearance, unless Nanox admits that the device is not novel. 

Cost confusion

How much does the fancy Nanox.Arc 2.0 cost to manufacture?

The original press release says $10,000, and it can do, among others:

• Real-time 3D imaging 
• Multi-spectral layering 
• Digital sync with treatment tools

CEO reiterated $10,000-$15,000, except for the first 100 units, on the Q4 2020 results call.

But Slide 41 in the January 2021 presentation says:

Costs tens of thousands of dollars

So, $10,000 or tens of thousands dollars?

Neither.

Any functional device that can do real-time 3D imaging, even basic tomosynthesis, will require a built-in detector that costs well over $100,000.

If we remove the real-time requirement and are willing to strap and completely immobilize the patient for over 4 minutes while taking the 45 projections for the tomosynthesis, then we can maybe possibly, however unlikely, get to $20,000, using the lowest-cost DR detectors, and assuming extra cheap hot-cathode dental tubes, HV generator, PC, etc.

Update:  The combined selling price of the three "analog" systems (which are actually quite digital, in fact) that are supposed to be replaced by Nanox.Arc 2.0, as shown in that slide, is less than $500,000, not "Millions of dollars" as the slide claims (actually, less than $400,000, if one leaves out the redundant Canon/URS U-arm machine)

Update:  Why is cost important?  First, the company has about $200 million in cash only, which will barely cover production and deployment of about 1,000 "working" non-fake machines.  Second, payback becomes moot (in the same presentation, Slide 27, the company claims $27,000 in estimated "minimum" annual revenues per machine) 

Update:  Of course, even if Nanox.Arc 2.0 were not fake, its design does not permit taking a Chest PA image, which is the most common x-ray procedure (but it can be easily done with either the Canon or the Shimadzu machine on the slide) 

The weight of a human, CE Marking, and the rest

The fake battery-powered Nanox.Arc 1.0 body scanner can withstand a human, according to a photo shown in June 2020 Haaretz article.

 

Nanox CEO and founder Ran Poliakine, January 15, 2020.source: Haaretz/LUZ Corporate Photography

So, what did the CEO tell the Israeli publication:

"The Nanox.ARC was distantly inspired by the sickbay of the 1960s television series Star Trek, where “Bones” McCoy would swipe a device over a patient to get a complete instant medical picture."  OK, so Nanox.Arc is fiction?

"On a practical level, the research and development was born of a failed project at the Japanese company Sony to develop LED screens."  Not OK - it was a failed project, but nothing to do with LED (light-emitting diodes)

"compared to just $10,000 and 70 kilos for the Nanox"  Not OK.  Nanox is now saying tens of thousands of dollars, and weight is no longer discussed.

"The company has applied for permits to the U.S. Food and Drug Administration, Europe’s CE and Israeli regulators."  Really, really not OK!!! There are no such "permits."  Nanox is now saying it has not submitted for FDA 510(k) clearance of the magic device, and that it has not submitted for CE Marking, and that means that it cannot register with the Israeli Ministry of Health.  

"Nanox is readying to install a device at Jerusalem’s Hadassah Medical Center to be used for developing novel early-detection and screening protocols to promote global preventive healthcare practices. Research is scheduled to begin the first quarter of 2021."  Not OK.  It is not happening.

"A [Sony] team worked on the idea [for a novel LED screen] for seven years at a cost of more than $1 billion. The project never yielded the screen because Sony canned it after Panasonic got to the market with a similar, lower-cost device. But along the way the team designed tiny silicon chips capable of creating consistent and exacting screenshot images, Poliakine said."  Not OK at all.  The story is quite a bit different, there was no $1 billion, and there are no such chips "creating consistent and exacting screenshot images."

"X-ray technology was developed at the end of the 19th century and to this day uses the same basic technology, based on heating a metal filament to 2000 degrees Centigrade."  Not OK.  The metal filament thing was invented in 1913 by General Electric (the former employer of Nanox Advisory Board chair).  Until then, X-ray technology used Nanox, that is cold-cathode, technology.

"The filament emits electrons that collide with an anode to create x-rays. The process uses a lot of electricity to keep the device cool."  Not OK.  Nanox process needs just as much electricity to keep the device cool.

"Nanox uses a proprietary silicon chip embedded with 100 million microcones that generate x-rays There are no moving parts, no need for cooling and no need for lots of electric power."  Not OK.  Nanox proposed tube performs exactly the same and uses the same power as a cheap Chinese tube unsuitable for medical imaging.  And, nope, Nanox does not have a novel tube that can be used in a commercial device. 

"Nanox ... employs 60 people, 38 in its Israel R&D center ad the rest at production facilities in Japan, the U.S. and South Korea."  Not OK.  Nanox has no production facilities anywhere.

Update March 25, 2021:  The original $1 billion thing seems to come from the June 2019 press release by Nanox predecessor (the current Nanox was incorporated in December 2018 but did not start "operations" until September 2019, per prospectus)

Update September 28, 2021: The April 2020 Hadassah press release says:

Over $1 billion and 15 years of development have been invested in revolutionizing the X-Ray source...

So, 7 years at Sony and 8 years at Nanox and Nanox predecessor?  Nope.  First, all Sony did was to send 6 "engineers" to the offices of Candescent to "learn" about the tech after it signed an agreement with it in November 1998 - there is no evidence that any independent devlopment.  Second, NanoX Imaging (Nanox predecessor) was "a multinational start-up established in 2012," but it was developing x-ray detectors not sources!

Random youtube comments

Some random comments, slightly edited, on youtube [and elsewhere]:

• If the FDA approves or clears a device that violates the laws of physics, would you still buy the stock of the maker of that device? What is more likely - that new laws of physics are discovered or that the FDA made a mistake? By the way, Nanox will not be asking for FDA approval, but for CLEARANCE (according to its SEC filings), which is a big difference.
• You don't need heat to "generate" electrons. For example, you can use photons to kick electrons out of metal.
• Almost 100% of the heat generated in an x-ray tube comes from the electrons heating the anode - only very little heat comes from the electron generation, be it from a cold or hot cathode.
  
  
• The more-powerful the x-rays are, the safer they are, ironically. Because the overall exposure in the soft tissues can be lower for the same quality of the image.
  
  
• Nanox tech paper and tech web page show absolute ignorance of x-rays and basic physics and engineering.  The scientific advisory board should be ashamed.
  
  
• Generating a good diagnostic "3D" image requires tens to thousands of images, that is exposures, but that's ok, because the overall radiation dose can still be quite low, if you have good detectors. That is why tomosynthesis and tomography machines are approved and cleared by the FDA.
  
  
• Someone made a good point about the lamb bone image possibly being exactly the same (same position/orientation) in the RSNA2020 demo. Modern x-ray console software has the ability to automatically straighten, auto-rotate and "line-up" an image, but it is a good point anyway and needs to be reviewed.
  
• If Nanox.Arc were real, it would be already deployed in a veterinarian "hospital" or even undergoing human trials.
  
  
• X-rays were discovered with a cold-cathode (gas-discharge) tube in 1895. Electrons from both the cold-cathode and hot-cathode generate heat when they hit the anode. About 99% of all the electricity used by an x-ray tube ends up in heat, regardless of the cathode. There is a lot of research being done now to find ways to generate x-rays without all this waste heat.  Nanox cold-cathode "technology" does not and cannot address that problem at all.
  
  
• Image noise is everywhere. Underexposed x-ray images are especially noisy. That's what cheap Chinese tubes do. Mechanical noise in the live RSNA 2020 demo comes from the tilting gantry, also known as Arc.
  
  
• The machine in the back of the warehouse is not an MRI machine. It is a Canon CT machine (although the radiologists think it is an inflatable prop, just like the company). Nanox will say they have it so they can use it as a predicate and compare Nanox.Arc images with the CT images in preparation for 510(k) submission of the multi-source Nanox.Arc. You cannot use someone else's "online" clinical images in a 510(k) submission - the FDA will reject such a submission.
  
  
• The Nanox industry presentation was on the original RSNA 2020 schedule, but, with the permission of the organizers, it was rescheduled to a later day.
  
  
• Ceramics might absorb too much radiation? Isn't that good? Plus, ceramic tubes are usually easier to manufacture in volume and last longer. So, almost all x-ray tube manufacturers also make ceramic x-ray tubes. But Nanox cannot manufacture them - Nanox ceramic tubes are fake.
• Nope, you don't need more voltage than 40kV to x-ray an adult hand, especially if you use a decent DR detector and no filtration (which is illegal, but so what!). However, the recommended exposure setting for tube voltage with a DR detector is indeed higher (and grid is also recommended).
• You would be surprised to know that the FDA has cleared diagnostic x-rays systems that use 2mA dental tubes. So, yes, Nanox can buy a cheap Chinese hot-cathode tube for $70, label it Nanox.SOURCE and offer it for sale for $100. Don't mix voltage with power - not the same!
• You don't need a great deal of energy to liberate electrons: https://en.wikipedia.org/wiki/Work_function .  As you can see from the work function, you don't need much voltage to liberate electrons. And, yes, nano-Spindt electrodes can do it with less than 50V in the real world.
  
  
• Nanox CEO cannot read about "atomic physics" - he studied art and calls himself a "technologist."
  
  
• Real scanners do use many KVP, much higher than 40kV.
  
  
• The detectors they have shown are Konica's AeroDr and DRTECH's Exprimer. I think they also use a cheap Chinese one ($25,000?).
  
  
• You can get plenty of cancer-inducing radiation even from one tube. For a CT-like reconstruction, you need to cover roughly 180 degrees, at the minimum, with your x-ray source(s).
  


• Yes, Nanox.Arc 2.0 is not functional - it cannot "scan" an adult.
  
  
• The agreement signed by the CEO of USARAD for the distribution of the 3,000 Nanox systems is illegal, I believe, because the Nanox system has not been submitted for clearance. And, yes, he himself admitted to have lied about whether he saw 3D images from Nanox in 2019. He makes false claims and pretends to cry during the RSNA 2020 "demo," because he is an investor in Nanox and wants to sell his stock at a high price. He is not a good radiologist, despite his certification - he failed to notice the mismarked hand radiograph during the live demo and lied about the recommended exposure settings for hand radiographs, among others. Also, he knew, or must have known, that the simulation results he presented were completely bogus, because the first thing one learns about cone-beam CT is the noise problem.
  
  
• The filament of a hot-cathode tube is heated over 1,000 degrees Celsius and uses very little electricity, as low as, say, 5W.
  
  
• Compared to a cheap Chinese hot-cathode tube, the proposed Nanox tube has the SAME size and shape, uses the SAME electrical energy for the same X-ray generation, requires JUST AS MUCH cooling, and is LESS precise in delivering that electron "beam." But, of course, Nanox cannot manufacture such a cold-cathode tube - I believe its demos use cheap LOW-POWER Chinese hot-cathode stationary-anode tubes that can operate at "room temperature." So, no, the Nanox tube is NOT LEGITIMATE - it does not exist as a functional device.
  
  
• SK Telecom President says that the proposed Nanox tube is VERY expensive. Yes, the cheap Chinese tubes can create "near-equivalent" images with a good DR detector (and the FDA has already cleared devices with only one 2mA hot-cathode tube), but Nanox is using them in its devices without the required filtration because they are so low-powered, which means they are unsuitable for medical imaging because they are unsafe (more likely to cause cancer!).
  
  
• Nanox cannot manufacture that "chip" commercially - it has no access to facilities to do so. Same about the tubes.
  
  
• Nanox and its predecessors have been trying to license these proposed tubes to other entities since RSNA 2015 (yes, for more than 5 years!), with zero success, per Nanox CEO and SK Telecom President.
  
  
• Nanox never planned to do a phantom scan with the single-source device - Nanox had already prepared the hand radiograph of the century video overlay (as revealed briefly in a frame in the video). In fact, the DICOM tag shows that the hand radiograph was the CEO's THIRD ATTEMPT ("Ran_3").
  
  
• The introduction of the Nanox.Arc by the CEO at RSNA 2020 was illegal and in violation of RSNA rules, as Nanox.Arc has not been submitted for 510(k) clearance yet.
  
  
• How many tubes in the Nanox.Arc as demoed - 5 or 6? What do those tubes look like?
  
  
• Nanox.Arc table cannot withstand the weight of an average adult - it is made of cheap thin wobbly plastic. Thus, the three light-weight phantoms used in the RSNA 2020 demo.
  
  
• Nanox.Arc cannot be used for mamo tomosynthesis - the devices cleared by the FDA require breast "squishing." No breast squishing means no 510(k).
  
  
• The animal bone scan with the Nanox.Arc was fake - it was prepared in advance, as evidenced by the wrong orientation (by 180 degrees) in the DICOM file.
  
  
• The reconstruction at the end of the RSNA 2020 demo was a misleading simulation - for example, it assumed no noise, while noise is the biggest problem with cone-beam CT. It also assumes giant x-ray detectors that don't exist and will cost millions, if ever built.
  
  
• Each of these opinion "leaders" in the Nanox "opinions video" said at least one thing that was false or non-nonsensical. Not a surprise here - they are paid by Nanox.  Money blinds and corrupts many people.
  
  
• We agree that tomosynthesis is computationally simple (matrix addition instead of matrix inversion) and very old (older than hot-cathode), but in recent years there has been increase in research and publications about it, because in certain cases, such as mammo or MSK or even chest, it COULD potentially generate good diagnostic images with less radiation dose than CT. Agree about the orientation, but you should take a good look at the RadiAnt DICOM viewer thumbnails in one of the frames of the recorded live stream from RSNA 2020. A side note: Nanox used a trial version of that DICOM viewer - they are too cheap to even pay for a $150 license.
• Did Nanox white paper on mammography disappear? The paper was called "Potential benefits of Nanox technology in Mammography" and was shown in Nanox virtual booth at RSNA 2020. Let me know, if you can find a link to a publicly available copy (I already have the actual file from RSNA 2020).

Added January 12, 2021:

• Please do not spread misinformation!  Where to begin... According to Nanox presentation at RSNA 2020, the single-source Nanox.Arc DOES NOT ANYTHING LIKE the multiple-source Nanox.Arc "but with one tube," as you claim.  The single-source device looks like the ugly device here, not the fancy and fake picture you are showing in the video!   On a side note, I have STRONG reasons to believe that Nanox has not submitted anything for clearance, either directly to the FDA or through a Third Party. Ok, back to the FDA:  The FDA is required to to respond within 30 days after the Third Party makes the recommendation (which recommendation should have occurred by early October 2020 at the latest, if Nanox response were satisfactory).  Here is what happens in the real world:  If Nanox had submitted for clearance, as it claims, the chance that the FDA is going to clear the device is now close to ZERO.  Similar DOES NOT MEAN substantial equivalence.  The device needs to be is AS SAFE AND EFFECTIVE.  Predicate is important, indeed.  Now, can you find a predicate for the ugly device?  Or maybe you can find one for the fancy fake Nanox.Arc device that cannot support the weight of an adult on the table (made of wobbly flaky non-structural plastic) and that cannot take proper chest PA, the most common radiological investigation in general radiology? Let's make it simple for you:  Since 510(k) is a preMARKET notification, the FDA or the Third Party should immediately reject any device that the submitter does not intend to MARKET.  And what did Nanox say about its plan to market the single-source Nanox.Arc device? Cold cathode companies?  Roentgen discovered x-rays using a COLD CATHODE tube (Crookes gas discharge one).  Cold-cathode tubes were the dominant tube technology, until GE (Coolidge) destroyed them in 1913   Every radiologist should know that!  Embarrassing.

Added January 13, 2021, this one from a chat room:

• @kastenz re do DIODES x-rays exist: [Nanox patents] won't help you here - they are almost completely useless because they are mostly misleading. Nanox predecessor has a research report about exactly how the [nano-cones] are made - they had to published it, because it was a requirement for using the university lab on the cheap with the other grad students. It has nothing to do with MEMS technology - it is a simple lithography and deposition. You cannot produce x-rays with semiconductor technology because of the work function - all you can do is UV. Nanox claims to produce x-rays like everyone else - generating electrons that accelerate with very high voltage, say 55 kV, and then hit an anode, thereby releasing 1% of the energy as x-rays. But yes, most x-ray tubes are diodes, including the proposed Nanox one (as in a vacuum tube diode, not a semiconductor one). Nanox, however, cannot produce a working tube, unfortunately (except for R&D). None of Poliakine's other ventures have been successful - all are complete failures. Nanopores - what is that? The holes/cones are about 100-300 nm or so in diameter [distance between cones 400nm to 800nm depending on the direction], if I remember from my measurements of their only microscope photo (which was hidden in a 2016 tech sales sheet by Nanox predecessor). MEMS use nanotechnology, because to make a functional micron-size mechanical part you need nano-precision. Nanox-proposed cold cathode does not use any mechanical parts - so it is not a MEMS device. The sources Nanox uses in its demos and tests are actually cheap Chinese hot-cathode tubes, based on what I have seen.

Added January 21, 2021:

• ​You have no opinion on the stock? That's news to me - your video description says Nanox (Nano-x Imaging) is revolutionizing the X-ray and this IPO stock will soon explode. Unless you mean explode as in get obliterated... Any radiologist who knows a bit of about x-rays and who listens to any interview or presentation by the CEO should immediately recognize that Nanox is a fraud - 1) Roentgen did not use a tube with hot filament (that was invented by GE much later, in 1913), and 2) 99% of the heat from the tube is not generated by the cathode but by the anode, and just about 1% of the electrical energy is converted into x-rays, regardless of the type of cathode used. I mean, this is basic stuff - and you don't need to know what device the CEO is talking about. Then comes the mass screening with ionizing radiation and all that other nonsense... And finally, the live demo - you saw the device he says he will be shipping this year. Tell me, what can that $50,000+ device be used for? It cannot withstand the weight of an adult and can't even do chest PA. I can't find any predicate for it.
  
• Nobody had seen images from the "tube" in October 2020? Hello? Nanox had those "images" in the prospectus. The problem with those "images" is that they are fake, not that they are regular "2D" images. How do I know? Well, the mAs and left/right labels change each time Nanox reposts these images. You claim to be radiologist, yet you have not noticed those discrepancies? How come? There were "CT" images (well, rotating 3D chest, not really CT slices) generated in the fake video that Nanox changed after MuddyWaters commented on it.
  
  So, did you like the images at RSNA 2020 and did you verify the machine produced them? Those tomosysnthesis images were not done real-time - it is easy to see in the thumbnail sequence of their trial-version DICOM viewer, so I have no idea how they were produced. But, yes, you can do some crappy tomosynthesis with 5 sources (not 6, as the CEO says), but it is useless for diagnostic purposes. And that 11-source simulation at the end was obviously misleading (because the main problem with cone-CT is noise, and SART is not the proper reconstruction algorithm), not to mention those detectors will run into $100,000s [even in high volume]. 
  
  Smaller places need a simple x-ray system first - that's what the World Health Organization says - and it is already cheap.
  
  
• Yes, "nanotubules."   Are you related to Dr. Dawson, the Nanox Advisor - he is the only one in the world that uses that word, and he does not understand it.
  
  Cold-cathode x-ray tube is possible.  Roentgen used one in 1895 to discover x-rays, and it did not have a rotating anode.  Cold-cathode had 100% market share in the x-ray tube market, until GE came in 1913 and destroyed it.  Today, there are cheap x-ray diagnostic systems (for extremities only) on the market that use 2mA hot-cathode dental tubes (tinier and cooler than Nanox' proposed source) without rotating anodes, of course.  But they can't be the primary imaging system, because they can't do regular adult chest x-rays.  Hot-cathode tubes with the performance proposed by Nanox are not expensive or large, and they cost less than $100 (while SK President and Nanox advisor says Nanox proposed tubes are very expensive in that removed video which you can see on my blog).
  
  Nanotubes and nano-pins (aka nano-Spindt) make a poor cathode for an x-ray tube.  The only commercial source for cold-cathode x-ray tubes in medical devices now is Micro-X, and all they could muster is a huge CNT tube that can just do 130ma for 2 seconds.  That is why their stock is down the drain and why Carestream is actively discouraging people from buying DRX-Revolution Nano which contains that tube.
  
  Nanox is not using any chip to control anything digitally.  It looks to me you don't even understand what Nanox is proposing as a cold cathode.  The "chip" is just a bunch of tiny metal pins close to a grid - that's all - there is nothing digital or MEMS about them.  With a Spindt (or nano-Spindt) array you control the tube current with low voltage, just as you do with a hot filament with even lower voltage.  And, of course, Nanox does not have any actual working source based on nano-emitters on a chip  - it cannot make it since it does not have the facilities to do so.
  
  All these opinion leaders you cite have already ruined their reputation, because they said stupid or false things in exchange for money in that video.
  
  But you are correct, irradiating the entire world population with ionizing radiation indiscriminately is not a good idea.  You should suggest that to Nanox CEO, because he disagrees.
  
  
• Yes, theoretically a stationary 5-source tomosynthesis machine that also tilts +/- 30 degrees (the proposed Nanox.Arc 2.0) can indeed produce some images, but they are definitely not slices (because tomosynthesis is additive, unlike CT, which is inverting) and they will be full of horrible blurring and striping artefacts, and, in fact, inferior for diagnostic purposes compared to simple radiographs taken from carefully selected views. 
  
  It is true that tomosynthesis evolved over time since the first attempts in 1920s, but then CT completely overtook it.  Only very recently there has been some increased revival with the approval of specialized breast tomosynthesis devices in 2013, but these are still niche products.  Nanox.Arc, even if it were real, is not the first x-ray imaging device that a hospital or an urgent care facility would acquire... 
  
  
• Nanox is not seeking FDA approval, but FDA clearance, according to its filings with the SEC.  Also, it is seeking clearance for a single-source device, which seems to transform each time it is shown to the public (compare RSNA 2020 with JP Morgan presentation).  Finally, there are reasons to believe that Nanox never submitted anything for clearance, or, if it did, it was fraudulently.

Added January 22. 2021:

• It is not a matter of choice - the ISRL ETF needs to track the index, by prospectus promises.  The weight is about 2% (divide 100 by 60, the number of companies in the index) - it is an equal-weighted index - and the ETF has some leeway with the weights based on liquidity.  NNOX was pre-determined to be included at the next quarterly rebalancing, once it did an IPO.  The move yesterday was due to OTM call buying, not the inclusion in the ETF at the close.  Funny thing, the more the stock moved up yesterday, the FEWER NUMBER of shares ended up in the ETF (you figure it out why!).  And that is why the stock is down today. 
  
  Also, why would an FDA clearance of a single-source device be important to a company that does not intend to market such a device (or, at least, did not intend at the time of the 510K submission)?
   
• not from youtube, but in the same line:  I have never said that Nanox "never submitted 510k clearance." I have said that I have (several) reasons to believe that Nanox never submitted for 510k clearance, or if it did, it committed fraud.
  
  The law says that FDA has to respond within 30 days to a recommendation by the Third Party whether to clear or not. Check my blog, or just google around.
  
  Nanox stated in its Prospectus that it submitted the single-source Nanox.Arc for clearance in January 2020. The problem is that in a draft registration statement filed with the SEC in February 2020, Nanox stated that it did not have a working Nanox.Arc device. Therefore, Nanox submitted a non-working device for clearance (which is fraud), or Nanox lied in its draft registration statement.
  
  In the same draft registration statement, Nanox also says that it planned to submit for clearance the single-source Nanox.Arc (meaning, it could not have submitted it in January 2020).
  
  And, of course, the single-source device shown at RSNA 2020 does not match the single-source device shown at JP Morgan conference.
  
  A single source tube is redundant (Nanox' proposed tube is a single source) and does not require clearance to be marketed. A single-source x-ray system device is not the same as a single source tube.
  

More (youtube and elsewhere):

• January 23, 2021: The chip proposed by Nanox (proposed, because it is not commercial!) is not a MEMS chip, because there is nothing mechanical about it. A MEMS chip is not made like a semi-conductor chip (otherwise, it will be called a semi-conductor chip).  Nanox has no manufacturing facilities in Japan or Korea [contrary to false claims in Prospectus and investor presentations]. The video [first posted in Nanox virtual booth at RSNA 2020] shows a University of Tokyo facility that prohibits commercial activities and an R&D (not manufacturing!) lab in Korea that is not a clean room and that cannot make chips.
  
  The Nanox ceramic tube is fake, because it cannot be sealed [to maintain vacuum], and because the chip cannot be made by Nanox (due to lack of facilities to do so).
  
  The single-source device is fake because it changed its look [from ugly to fancy] between RSNA 2020 and the JP Morgan presentation [, and size, shape, and functionality changed too].
  
  The FDA does not care about any x-ray tubes [they are Class I devices exempt from premarket notification and clearance]. The FDA cares whether the x-ray SYSTEM (the complete device) is safe and effective. Nanox has not submitted anything for any FDA approval, according to its prospectus.
  
  
• January 25, 2021:  Dear Doctor,  Cathy's IZRL was forced to buy Nanox at the quarterly rebalancing because Nanox did an IPO in August.  That is how passive index funds work.  She did zero due diligence on the stock and had to buy it, even knowing that Nanox is a fraud, that's what the prospectus says.  Cathy does not care whether the stock goes to $1,000 or zero - IZRL has to own it, as promised in the prospectus - Cathy needs to track the benchmark.   Nanox is not designing a CT scanner - you cannot do CT with less than 180 degrees of projections, by definition.  The heating of filament does not create "x-ray imaging," and neither can any silicon chip.  The demo at RSNA 2020 was not live - it was live-streamed across oceans and continents  - big difference (and, of course, the CEO faked it).  January 2020 (510K submission) comes before September 2020, not after!   What you are circling on the presentation is NOT A SILICON CHIP - it is a glass tube that Nanox claims it is no longer using.  Nanox is not seeking an FDA approval, according to its prospectus  (the first presentation slide is intentionally misleading!) - approval takes years of human studies and billions of dollars, while clearance is done within 90 days.  If you want to learn more about how FDA clearance works and how long it takes, look at my blog.  The company is confused about what is the meaning of "field" in "field emitter."  Yes, if the company were not a fraud, all would be great and cancer and appendicitis would be cured for pennies, but it is a fraud.
  
  
• February 1, 2021:  According to Nanox, the FDA is now requesting information about the predicate and intended use for the single-source device only (the fancy, but also fake, Nanox.Arc one has not been submitted yet). If I were the FDA, I would do the same. Why? Because Nanox stated in its Prospectus that it did not intend to MARKET the single-source device , and the 510K submission is a preMARKET notification. I other words, the single-source device has no intended use (and therefore, no predicate).
  
  
• February 1, 2021:  In response Andrew Kamal @Medium, an avid reader of my blog:  So, what exactly is your problem with my blog? You find the single-source device non-ugly or the Nanox.Arc, in general, non-fake? Or you just think that this SUPER NANOX soap is infringing on Nanox' copyrights? Has anyone of those "smart people," who may be paid by Nanox, confirmed that Nanox is not a fraud? Since Nanox is a fraud, you won't find such a confirmation, I am afraid. Ark's IZRL fund had to buy NNOX and did it with zero due diligence because it is a passive fund that tracks an equally-weighted index of all the liquid publicly traded tech Israeli stocks, and gets rebalanced quarterly (NNOX was eligible for the first time). FDA timeline getting close - you sure? You were correct on the big move today, though.

Update:  March 24, 2022:  Tonsley Innovation District said before the launch of the Carestream DRX-Revolution Nano device:

It is expected that the revolutionary machine will be available for commercial sale next year via Carestream Health between $150,000 to $200,000 per unit.

I have not seen a disclosure by Micro-x itself about the ASPs of the Nano or the Rover.