If you build it, who will use it?

Nanox.Arc device, as it stands today, is fake.  But what if Nanox used its $200+ million cash to actually design and build its proposed device?  Will it be useful?

Nanox claims that its proposed device uses a modality ("imaging technique") - tomosynthesis - that is supposedly "widely used for early detection" of something.

Subject to receiving regulatory clearance, the first version of the Nanox.ARC that we expect to introduce to the market will be a 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 (annual report, page 56)

Tomosynthesis (previously called x-ray tomography, focal plane tomography, etc) has been available since 1930s - it should not to be confused with CT or computed tomography, which can visualize axial slices and individual voxels.  

tomosynthesis vs. plain, per Nanox demo at RSNA 2020 

Even though various medical device manufacturers have pushed it over the years, its use has never been wide.  It never added much to simple x-rays taken from different views... 

In 1993, the American College of Radiology (ACR) started work on developing guidelines for radiology to eliminate inappropriate utilization of radiologic services.  Today,

ACR Appropriateness Criteria are evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for a specific clinical condition. Employing these guidelines helps providers enhance quality of care and contribute to the most efficacious use of radiology.

Of the nearly 1,000 radiological procedures covered by the criteria, only three are based on tomosynthesis, and all three involve breast tomosynthesis, which is usually appropriate for breast cancer screening and diagnosis:

• "Digital breast tomosynthesis diagnostic"
• "Digital breast tomosynthesis screening" 
• "Digital breast tomosynthesis short-interval follow-up"

Elsewhere, tomosynthesis is mentioned maybe a couple of times in the narrative discussion or literature search as part of the regular x-ray modality analysis (for example, here and here), but clearly it is not significant enough to deserve any attention as a specific imaging procedure indicated in specific diagnostic scenario.

The real problem is that the proposed Nanox.Arc cannot perform digital breast tomosynthesis, contrary to Nanox claims in March 2020 about no-squish mammography.  In its own mammography white paper, Nanox admits that breast tomosynthesis requires compression (squishing) and a completely different mechanical design, which makes scanning of other organs, such as lungs, impossible.

So here we have it.  According to the American College of Radiology evidence-based guidelines, the use of Nanox.Arc, as proposed, will not be "usually appropriate" under any clinical scenario.

To make this fit into the hole for this

Nanox tube video exposes a problem with the fake 25 Nanox.Arc devices that Nanox claimed to have completed, and the 1,000 devices for which it claimed to have sourced all the metal parts.

Here are the holes for the x-ray tubes in the devices (3 shown, out of 5 holes).  Nanox never filled those holes with tubes.  

https://twitter.com/nanox_vision/status/1384873902766231557

And here is the new Nanox tube.

Nanox has to find a way to make this glass tube fit into the hole and housing (head) designed for the fake ceramic tube, which was shorter and which had an x-ray exit flange closer to the cathode end.  By just looking at it, drilling new holes, manufacturing an adapter, and repositioning (tilting/rotating) the tubes won't be enough - substantially the entire metal enclosure needs to be redesigned, manufactured, and reassembled.

NASA may have had an easier job.

"We gotta find a way to make this fit into the hole for this using nothing but that.”
a scene from Apollo 13 (1995):

Still a scam

If the recent Nanox tube video was meant to demonstrate that Nanox is not a fraud and the Nanox tube is real, it failed.  The video is misleading and self-contradictory.

The video shows that the new "high-power" tube is very similar to the rest of CEI's low-power hot-cathode tubes made of glass, but is of subpar power.  For example, the control software screenshot shows that the tube supposedly operated at 100kV and 1mA for 40 seconds.  However, CEI's "3D" tubes, or tubes designed for cone-beam CT medical devices, can do 1.5mA (model OX/100) or even 4mA (model OXC/100) at that tube voltage indefinitely, based on the anode's cooling rate, and can be smaller, contrary to the the text on the video (model OX/100 is shorter than the 5-inch-or-so "finished" Nanox tube shown in the video).

Also contrary to the text in the video, the supposed Nanox tube is not cheaper to manufacture than CEI's regular hot-cathode tubes (a chip will always cost more than a filament).  There are simply no "special cooling and rotation mechanics" in any of the tubes made by CEI, which makes stationary-anode tubes exclusively.

 

Nothing in the video shows any "digital" operation either.  The tube works just as any other regular hot-cathode x-ray tube made by CEI - electrons emitted by the cathode get smashed into a metal target (anode), and about 1% of the energy released comes out as x-rays.  The video does not show how the electrons are generated - Nanox white paper says about 50V is needed at the "gates" grid on the chip, but the control software screenshot confusingly shows the typical 4.1V that is used for heating the cathode (although no filament current, "A fil", reading indicates that circuit may have been disabled).  

Finally the text of the video is misleading as it claims that the current x-ray technology has been used for over 120 years.  Nanox own white paper states that the "modern" hot-cathode technology was invented in 1913 by Coolidge - that is less than 120 years ago.  Roentgen discovered x-rays over 120 years ago, but he used the outdated cold-cathode technology, the one that Nanox is proposing.  

In summary, the video does not really prove that the Nanox cold-cathode "technology" works or that it even exists. 

Modern tube production, according to Nanox

Nanox shows how a modern tube production facility looks like in the new "tube" video on its website (an exact copy of the video leaked a few days ago).  No comments should be necessary.

Rust, paper, damaged insulation, and a bare hand contaminating a mystery tube element that appears to be checked for continuity with an incandescent (hot-filament) lightbulb.  But can you blame the poor CEI?  The Chinese competition has copied its tubes and offers them at half the price, at about $100 on Alibaba (Kailong's catalog, pages 4,5).  CEI claims to have spent 600,000EUR on technology since 2014 "for expanding the range of products and for reducing tubes costs."  Apparently, that wasn't enough.

Update May 1, 2022:  Nanox rereleased this video on YouTube, then it made it private recently (sometime earlier this year, I believe), and now it still lists it in the media section of its website.  Clearly, CEI is no longer a tube OEM partner of Nanox, having failed to produce even one working Nanox tube, just like everyone else who has ever tried (not a surprise, since the core component, the Nanox.SOURCE chip, is simply fake).

One of the many problems with this video, other than the fake tubes, is that it reveals Nanox own confusion about its core technology, the Nanox.SOURCE chip.  For example, here Nanox claims that its fake Nanox.SOURCE chip is a "novel digital x-ray source."   Yet its technical white paper describes the chip as a source of electrons.  Electrons are quite different from x-rays, which happen to be photons.  And, of course, there is nothing novel or digital about it - this is a failed 1970s technology (Spindt array) and the x-rays made by a tube using it is just as analog as any other x-ray tube - electrons gets smashed indiscriminately into a metal target to make x-rays.

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). 

 

A lie about 1,000 tubes

One of the Nanox promoters now wants the CEO removed to an Executive Chairman role, for various reasons.

One of the reasons - the 1,000 magic x-ray tubes that vanished (the 10 fake Nanox.Arc "produced" in November 2020, and the 25 fake Nanox.Arc "produced" in March 2021 were already addressed on this blog).

So, yeah, on the March 2, 2021 results call, the CEO insisted:

So again, just to clarify, for 2021 shipment, which is 1000 units, we are all set. We have secured actually everything we need in terms of chips and tubes and actually metal parts for the system. So for the 1,000 systems that we intend to make and ship this year or latest first quarter of next year, we are set.

He said today that the tube "supplier" is having some problems finishing and testing those tubes.  Poof, 1,000 tubes vanished.  Actually, they were never real - as discussed on this blog, Nanox has no ability to obtain the chips that are supposed to go into these proposed tubes, because the Japanese university labs it claims to be renting prohibit commercial use.   Moreover, the tube assembly Korean "facility" that Nanox showed in a video during RSNA 2020 was labeled "R&D," with no apparent vacuum sealing capabilities - so no assembly there either.

Update May 12, 2021:  Of course, it was not a thousand tubes.  Each of the first 1,000 Nanox.Arc devices is now supposed to have 5 tubes, bringing the number of disappearing tubes to 5,000 (plus spares).

This head here has this tube inside

The CEO got caught lying again, and the RSNA 2020 demo was fake.  

On the Q1 results call today, the CEO revealed that the Nanox.Cart device that received FDA clearance has a glass tube, not a ceramic tube.  But at the RSNA 2020 he said (about 5:27 into the video stream):

... this head here has this tube inside...

He was, of course, holding a ceramic tube, not a glass tube.  He now says Nanox is experiencing delays in manufacturing of said ceramic tube.

But maybe the head belongs to some other Nanox.Cart, not the one submitted for clearance?  Well, no.  Next to the device there is a sign saying "pending 510(k) clearance" and the Nanox.Cart is the only Nanox device ever submitted for clearance.

The Nanox.Cart is the only device submitted clearance

And we confirm again with Slide 22 from the April 2021 investor presentation that the ugly device with the enormous head containing "cooling fluid" is the Nanox.Cart.

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.  

Another confirmation that Nanox.Arc is fake

Nanox tweets a short video today, confirming that Nanox.Arc is a non-functional fake "future product," rather than a real device in production.  So much for the 25 devices that were supposed to have already been made in March - they must have been all fake, too. 

 

Notice how the two assemblers just carry the arc with the empty tube housing and mount it on the device base.  No x-ray tubes means the device is non-functional and fake. 

The device also appears to lack a detector - the table is put directly over where the detector should have been.  Just another reason why the device cannot take any images and is fake.

But the two 12V batteries in the base below where the missing detector should have been may be real.

More later.

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)

The tube chart that proves that Nanox is a fraud

Nanox team does not (or pretends not to) understand basic x-ray physics and engineering.  Its "technology" webpage and white paper are full of false, nonsensical, and self-contradictory statements.

Probably the single best example is the chart illustrating the supposed superiority of Nanox "core technology" - a novel chip-based cathode incorporated in a novel x-ray tube (see page 55, annual report).  

the chart, with enhanced saturation and added 42MW label

The chart is prominent on the technology webpage and in the white paper, where it is labeled "Hight [sic] Voltage independence" (Figure 9).  The chart title "T-35 Gate-2 HV/Ia independence" is not explained anywhere, but apparently refers to a Nanox Tube with diameters of 35 mm, utilizing a gate version #2 (as supposed to version #1?), and showing the independence between the tube (high) voltage and the tube (or anode) current (Ia).

Nanox T-35  tube that needs 42MW of power

The chart is supposed to demonstrate that Nanox cathode can enable "specific current irrespective of the anode ‎voltage."

But the chart is completely non-sensical, for at least four different reasons. 

1. The current scale is simply wrong.

Nanox does not know how to write numbers using simple scientific or engineering notation.  Jeremy Rutman is more diplomatic when he states: 

we note that whoever produced this graph forgot to use a negative exponent for his/her current units.

The vertical (current) scale in the chart goes like this: 0A, 2,000A, 4,000A, 6,000A, 8,000A, 100A, 120A.  Note that the tube current in the most powerful x-ray tubes in medical diagnostic devices is less than 1A, and notice the sharp drop-off after 8,000A.

If we take the point on the Ia (tube current) line at about 6kV (or 6,000V) tube voltage, the current is about 7.0E+03A (or 7,000 A), which corresponds to power requirement of about 42 megawatts (42,000,000 W) to power just one Nanox tube.  That is the power output from the massive generator of a small power plant:

a 40MW generator

a modern 40MW power plant 

2. The tube voltage is too low

The tube voltage on the chart does not go above 30kV.  If Nanox cathode (and tube) can only withstand 30 kV tube voltage, then the tube cannot be used in diagnostic medical devices, except to perform mammography.  Nanox own technical paper states in the section with the chart:

Typical kV in radiography range from 40-120kV and 22-49kV in mammography

The problem is that a mammography tube needs to withstand currents up to 100mA, while the chart, even with  a "fixed" scale where + is replaced with -, shows that Nanox tube can do no more than 1.1E-02A, or 11mA (unclear for what fraction of a second).

Moreover, neither the ugly Nanox.Cart nor the fancy-but-fake Nanox.Arc devices can do mammography due to their design, and Nanox removed the link to the easter-egg mammography concept device from its webpage.  

3. The chart demonstrates nothing

The chart is clearly using made-up data rather than actual readings.  That is not surprising, as Nanox cannot manufacture the proposed chip (has no access to facilities to do so commercially) or assemble the proposed (ceramic) tubes.  Moreover, even if everything was ok with the chart, it still shows nothing special about Nanox cathode or tube.  Most modern x-ray sources are required and designed to maintain independent control of tube voltage and tube current, that is "HV/Ia Independence."

4. Energy is not measured in volts, and current is not power

The description of the chart on the webpage even shows ignorance of the difference between energy and tension and how each is measured:

The Nanox gate electrode practically "ejects" the electrons from the ‎cathode and controls the amount of X-ray radiation, enabling independent control of ‎the X-ray current (mA tube current) and the energy (kV) that is set at the Anode. ‎

While there is a relationship between the x-ray energy and the tube voltage, energy is not set in kV - tension (or voltage or potential difference) is.

Elsewhere on the tech page, Nanox claims that with its cathode technology 

the current's power is independent of ‎the voltage

But the current's power is very much dependent on voltage - in fact, power is current times voltage.

Update July 1, 2021:  The 510k summary shows that the "Nanox tube" described in the submission can't do more than 2 mA and it can do it only at 40 kVp tube voltage, confirming the tube chart in the white paper is complete fake and fraudulent. 

Update October 9, 2021:  The fraudulent chart is still present in the "updated" white paper (updated in August only with the new Nanox logo).  Even replacing + with -, the chart would still show 11mA, or more than 5x the value in the 510K summary.

How live was RSNA 2020?

The CEO insists that the RSNA 2020 demo was live.  But was it really live, or was only the artist performance live?

An observant anonymous commenter to this blog noticed the presence of two interesting batch files on the radiologists' displays, obviously prepared well in advance.

partial snapshot of the live recording, about 8:45 

  

The first one is named Reconstru*.bat (as in tomosynthesis reconstruction from plain 2D images), and the other one is named RSNA.bat.  Why did the radiologists and their helpers need those "automated" series of software instructions?  How live was the demo, really?

There are two other thumbnails/icons.  One is a shortcut to the RadiAnt DICOM viewer, a low-cost but capable viewer for x-ray images.  Interestingly, Nanox did not pay for the software and was using it on a trial license - not really a good sign for a company that was and is supposedly doing all these x-ray image tests in preparation of an imminent 510(k) submission...  The other thumbnail is a file folder named "live Nogah," in honor of the radiologist Nogah Shabshin, who was commenting on the (supposedly) live images during the (supposedly) live demo (and forgot to disclose its Nanox affiliation during her other RSNA 2020 presentation).  Why would she have her own file folder on Nanox equipment?

News in Nanox annual report

What's news and notable in Nanox annual report, relative to the Prospectus filed in February? 

Material weakness

We have identified a material weakness in our internal control over financial reporting in connection with the audit of our financial statements as of and for the years ended December 31, 2019 and 2020. (page 49)

Oops.  That's even before any revenues are recognized.

Dangling chips 

 As mentioned above, we currently manufacture the MEMs X-ray chips in the clean rooms located in Tokyo, Japan (page 15)

Nothing like it is mentioned above (in the annual report).  The rest of the statement, of course, is also false - the clean rooms located in Tokyo, Japan do not allow commercial use, and therefore Nanox cannot manufacture the proposed "digital" x-ray source that relies on those chips (and, in reality, there is nothing digital or MEMs about them).

 

No working Nanox.Arc

Although we have produced a working prototype of the Nanox.ARC and developed a prototype of the Nanox.CLOUD, we have not produced any of the approximately 15,000 Nanox.ARC units planned for the initial global deployment under the contract manufacturing agreement with FoxSemicon Integrated Technology, Inc., a subsidiary of Foxconn (“FITI”).  (page 7)

So, one working prototype of Nanox.CART, the one that got cleared?   But no working prototypes of Nanox.Arc?  Is this an admission, finally, that the RSNA 2020 demo of the Nanox.Arc was faked?  Why couldn't Nanox complete even one of the 10 prototypes that Nanox was supposedly assembling in November 2020 (according to the Q3 2020 results call)?  What happened to those mock-ups in all these production photos pushed by Nanox and its promoters this year?

A side note here:  Nanox never signed an agreement with FITI, according to the text of the contract manufacturing agreement.  The agreement was signed with a Japanese company that is not a Nanox subsidiary, according to public corporate records.

No ceramic tubes

We are evaluating, subject to completion of testing, a transition from glass-based X-ray tubes to ceramics-based tubes for cost efficiency purposes, which are the tubes to be used in the multi-source version of the Nanox.ARC, and we intend to enter into an agreement for such ceramics-based tubes with a new manufacturer in the future. (page 14)

That is, Nanox still cannot manufacture the ceramic tubes that the CEO claimed were used at the RSNA 2020 demo of both the Nanox.Cart and Nanox.Arc.  So, the RSNA 2020 demo was fake and the FDA 510(k) submission may have been fraudulent.

Fuji is out

We have not entered into any licensing agreements; however, we expect to enter into negotiations regarding a commercial arrangement with FUJIFILM Corporation for the licensing of our Nanox System. Any of the above factors may negatively affect the implementation of our Licensing Model, or cause our Licensing Model to fail. (page 12)

This is an admission that Fuji is not a Nanox Mamography OEM (that is, all Nanox investor presentations so far have been misleading ).  In the Prospectus, Nanox still falsely claimed:  

We are currently discussing the terms of a potential commercial agreement with FUJIFILM Corporation.

Chinese tubes 

We have, and expect to enter into, agreements with manufacturers and/or suppliers in China for the production of our X-ray tube, the Nanox.ARC and some of their respective components. (page 23)

Is this an admission that Nanox is using a regular low-cost, low-quality, hot-cathode Chinese x-ray tube and calling it "digital?"

 

A confused FDA: Cart or Arc

 

... we submitted a 510(k) premarket notification for the Nanox Cart X-Ray System... in January 2020... On January 30, 2021, we received additional information requests from the FDA which, among other things, require us to address certain deficiencies and questions, including requests that we provide additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate device. We submitted our response to these requests on March 1, 2021. On April 1, 2021, we received clearance from the FDA to market our Nanox Cart X-Ray System. ...we may seek alternatives for commercialization of our Nanox Cart X-Ray System.  (page 32) 

Why was the FDA asking about Nanox.Arc in January 2021?  The device that got submitted and eventually got clearance is Nanox Cart X-Ray System, that is, the ugly Nanox.Cart, not the fake Nanox.Arc. The FDA should have asked about Nanox Cart X-Ray System, no?

Nanox also confirms that it still has no plans the market/commercialize the Nanox Cart X-Ray System even after its pre-market notification got cleared.

Update:  Muddy Waters tweets about Gilad Yron, the Chief Business Officer, no longer counting as an executive, which I missed (it is not clear what his current role is, if any). 

Update April 8, 2021:  Fixed some spelling.  Also, the Nanox.Cloud prototype developed by Nanox is just a collection of a few mock-up screens that use stolen images and contain non-sensical findings.  

Pumping while selling

 The CEO went on Bloomberg yesterday to pump the stock.  

He did not tell the audience that he put an order to sell 1,003,931 shares just hours earlier (at a low expected price of about $41).  The CFO sold only 40,533 shares.   Both selling according to a 10b5-1 selling plan supposedly adopted on March 4, 2021 (but that plan was not disclosed in the two prior 144 forms filed by the CEO)...  Nice.

There are some gems in the Bloomberg interview - more later.

Update April 7, 2021:  

Gem #1:  The tube the CEO is holding, while selling his shares, is fake, non-functional - it appears the vacuum sealing has failed (if there was ever one) - and cathode elements are falling off...

Gem #2:  5 tubes in Nanox.Arc, not 6.  The CEO insisted on 6 tubes in Nanox.Arc (and finalized design) at RSNA 2020. 

Gem #3:  The predicate device for Nanox.Cart is one of GE machines.  That indicates potentially fraudulent 510(k) submission, as all GE machines (that I am aware of) under the IZL product code can do Chest PA, the most common x-ray image done in the world, while Nanox.Cart, as demoed at RSNA 2020, can't.  The upcoming 510(k) summary should shed more clarity here.

Update December 12, 2021:  The interview is still available on Youtube.  The CART is not cleared for chest, only for hands, wrists, and fingers.

Nanox announces FDA clearance of something

According to the press release, Nanox

single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the US Food and Drug Administration (the “FDA”).

Quite interesting, since the FDA, by law, cannot clear a technology, only a device.  It is also interesting that the mythical single-source device is nowhere to be seen on/in Nanox website, SEC filings, investor presentation, or any other marketing materials or white papers. .

an ugly device demoed at RSNA 2020

 

Nanox also confirms that it does not intend to deploy the device for which it received clearance:.

The Company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the Company’s commercial imaging system that it expects to deploy broadly across the globe.

That is really interesting, as 510(k) clearance is also known as pre-market notification, so it makes little sense to clear a device that it is not intended to be marketed.

But what is truly astonishing is that Nanox does not state in its press release that the device uses Nanox proposed "cold-cathode" x-ray source.  So does the device that just got cleared use a regular hot-cathode dental tube?

As of now, there is no public confirmation of the clearance by the FDA.  On Monday morning, the FDA should update its clearance database, and if the device got indeed cleared as Nanox claims, we will learn the product code, the name of the Third Party, and the date the Third Party recommended clearance, if there was any Third Party to begin with.  But we will have to wait for 30 days to read the Summary, where the predicate, intended use (extremities only?), and some tech characteristics will have to be made public...  And then Nanox will have some explaining to do - how do you enable early detection of cancer (also known as Nanox vision, or the oxymoronic "screening of symptomatic patients"), when all you are cleared to do is image broken wrists or feet?

Update April 4, 2021:  There is an argument floating around that an FDA clearance proves that the company is not a fraud.  The argument is flawed for at least three reasons:

1. Nanox claims that its Nanox.Arc device is novel.  A clearance, however, means that the company demonstrated that the device to be marketed is substantially equivalent to a legally marketed device.  Oops.  How can it be novel, if it is substantially equivalent to something already on the market?
2. A clearance is also known as pre-market notification.  But Nanox says that it has no plans to market/sell/ship/commercialize/deliver/deploy its single-source device.
3. Theranos, the fraud, also got clearance (in July 2015) for a device it did not intend to sell.  By January 2016, the federal government was after it.

Update April 5, 2021:  According to the FDA database, the device that was cleared is a cart - "Nanox Cart X-Ray System" - notice it is not named a (single-source) Nanox.Arc.  The product code is IZL (a mobile x-ray system).  There is no product code for a detector (MQB), so the device has no built-in detector, and so it cannot take images by itself (but should be able to use any $25,000+ cleared detector).  The clearance was recommended by a Third Party, Accelerated Device Approval Services, on December 28.  The summary should be released around May 1st.

KvP / mA - the shocking proof that Nanox is a fraud

Nanox prospectuses are riddled with false and misleading statements some consider to be material.  Here is a recent example that always trips Nanox promoters.

In a paragraph-long section in the latest prospectus titled "Multi-spectral imaging capacity using one X-ray source" (pages 83-84), Nanox states that it has (only) one "working prototype" and that prototype "uses 60 KvP / mA."  

The elaborate and nonsensical explanation of this novel metric, KvP / mA, may simply be a roundabout admission that the prototype's tube (almost certainly an "analog" dental/industrial one, with a hot-cathode and of low quality) can handle no more than 60 kV tube voltage.  Such a low tube voltage would render it ineffective for general diagnostic imaging (but could be ok in special cases, such as extremities, depending on its remaining tech characteristics).

Nanox mentions the "KvP / mA" metric five times in that section with the exact same spelling, and refers to it interchangeably as "a ratio" or "a combination" that demonstrates the superiority of the "novel" x-ray source, and that reflects "complete independence and separation between the strength of X-ray penetration and the amount of photons for illumination."  Elsewhere in the prospectus, Nanox claims that a slightly different spelling, "kVp/mA," represents energy with its acceptable range of values specified in industry standards:

The Nanox.ARC, using our X-ray source, is being designed  ...  to have a full kVp/mA energy throughout range as per industry standards (page 85) 

According to Nanox, the first component of the metric, KvP, "represents the speed of electrons that gives the X-ray its penetrating power," rather than misspelled tube voltage.  The second component, mA, "represents the amount of photons or brightness levels of the X-ray image," rather than tube current.

Ok so far?

Nanox then proceeds to make various assertions about modern x-ray sources:

For legacy X-ray sources, KvP / mA ratios were codependent in a linear relationship and each X-ray source could only produce one set of KvP / mA combinations dedicated for a particular use (for example, either tissue images or bone images, but not both simultaneously).  We believe our X-ray source technology can produce multi-spectral imaging from one X-ray source, which allows for variable energy levels to be controlled during one scan.  With multi-spectral imaging, one source chip can be used for multiple types of scans, such as head-scans, abdomen, mammography and angiograms, involving both soft and hard tissues at variable densities, simultaneously.

Those claims translate into the following false statements:

• modern diagnostic x-ray systems cannot image human tissues
• a bone is not made of tissues
• a particular intended use requires only one specific tube voltage/tube current combination
• tube voltage cannot be controlled independently of tube current in modern systems
• modern systems cannot vary photon energy levels (for example, by varying tube voltage) while scanning
• the relationship between tube voltage and tube current in modern x-ray sources is only linear
• it is impossible to use the same modern x-ray source for imaging tissues of different densities or for different radiological scans/examinations

Nanox then illustrates the "functionality and capability of multi-spectral (separation) imaging" of its proposed novel x-ray source, apparently not to be confused with modern spectral or energy-resolved imaging.

According to the diagram, a Nanox device can image six separate sets of body parts by using six different tube voltages and a fixed tube current, that is, six different ratios of tube voltage and tube current, which appears to contradict the single "60 KvP / mA" ratio that Nanox claims to be using.  The diagram also implies that imaging blood vessels with the proposed novel source requires much higher tube voltage than imaging lungs, and that the difference in tube voltages between imaging blood vessels and lungs is 5x the difference in tube voltages between imaging bones and lungs (worse, if the chart uses a log scale).

If all this was too long or too technical to read, here is the summary:  there is no such thing as KvP / mA or multi-spectral imaging.  That is Nanox for you.

Update:  Nope, not an April Fool's Day joke.

Update:  Nanox predecessor called all this "Independant [sic] KVP [sic] /MA [sic] control."  It also called it "5D X-Ray Multi-spectral imaging"

We call it the 5th dimension of X-Ray, the ability to create an MRI like multi-energy derived image, which provides a novel separation between bones, hard tissue, soft tissue, lesions, cardiovascular system and more. ‍

Quite exciting, given that MRI has nothing to do with x-rays (it is a completely different technology) and that the old-style legacy 4D energy-resolved x-rays operate only in the four dimensions of space-time.  But then something happened, and Nanox never mentioned 5D ever again, to my knowledge.

Update:  Of course, kVp and mA are independently controlled in virtually all x-ray devices using legacy x-ray tubes, going back to year 1913 (some portable x-ray medical devices have fixed kVp and/or mA, for simplicity).