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.  

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.  

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). 

Marketing vs reality

Nanox greets us this morning with another tweet, as it is about to fail its milestone which called for "FDA approved" by the end of the day today.

Wow, that proposed "digital" source will make x-ray systems not only affordable, but cool and multifunctional, too?  

Guess which of the two devices below belongs to Nanox?

Device 1.

Device 2.

Nanox claims that the ugly Device 1 is the only one it has submitted for FDA clearance and it does not intend to market it.  Device 2 uses the 100-year-old technology, and so does Nanox device, I believe, even though Nanox denies it.  Device 2 has been on the market since last year.

Update:  Nanox failed to get "FDA approved" in Q1 2021, and missed its "milestone."

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device).

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.

The chip that proves that Nanox is a fraud

Nanox tweets how its "small" chip is changing 100 years.  That would be quite a feat, if the chip were not fake.  But it is easy to see that it is fake.

 

Let's magnify:

The things in the red ovals are either defects or large specks of dust (which should not exist in a clean room).  The chip is not functional.

Why doesn't Nanox have a better picture of the chip?  Nanox has no access to facilities to manufacture the chip, contrary to the false claims in its Prospectus.  Specifically, Nanox claims to have its own equipment placed in clean rooms at the University of Tokyo.  However, there is no equipment that belongs to Nanox there.  Moreover, the University of Tokyo prohibits any commercial use of its clean room facilities, which it rents per day to anyone who is doing academic research. 

The proposed chip, even if manufactured without defects, changes nothing.  The proposed chip requires much higher voltage than a corresponding filament, first introduced by GE in 1913.  The proposed x-ray tube with such a chip in the cathode generates just as much heat as a regular tube using a filament (since 99% of the heat in both tubes is generated at the anode and 99% of the energy used by both tubes is wasted as heat).  Switching speed is the same as a regular tube with a grid.

Update:  Another view of the chip, from a snapshot of the RSNA 2020 "Nanox - Technology & Vision" video (1:02).

Side by side

Nanox tweets "It's time to move forward. It's time for Nanox."

Maybe it is the Twitter limitation, but it is not clear what Nanox meant to write.

On the left, we have Hologic EPEX digital x-ray system, introduced in 1999.  On the right, we have a device that simply cannot take Chest PA, the most common medical x-ray image worldwide, even if it weren't fake.

Is Nanox finally admitting that the latest version of its multi-source device, the one that Nanox is promoting here, is the equivalent of an ancient x-ray machine?

The Hologic system had an introductory list price of $395,000.  Nanox says free, $10,000, or tens of thousands of dollars, depending on the day.

Please let me know, if you know the clearance, or 510(k), number for the Hologic device.  The Nanox device has not been submitted for clearance, according to Nanox.  Therefore, it cannot be promoted.  "For demonstration purposes only" does not really cut it, but that's for the FDA to decide, of course.

Update:  Here is how one more modern and cleared x-ray machine looks like (list price is below $10,000, I believe, detector excluded).  X-ray is not x-ray, it seems.

Nanox CEO caught lying again

According to Nanox CEO, 

SK Hynix is one of the largest MEMs manufacturers in the world. 

That is an outright lie.  Here is the ranking of the top 30 MEMs manufacturers in the world.  SK Hynix is nowhere to be seen.

Source:  Yole via EETImes.eu

Nanox mission

 Not to be confused with Nanox vision (announced in a press release with SKT in June 2019), Nanox mission is:

“to replace all legacy sources with our digital X-ray.” (November 2019 press release)

From/To in Nanox November 2019 press release 

Yes, that digital X-Ray source has a field of nano-gates (that is, holes) that emit pixie dust (because electrons are emitted by nano-cones, not nano-holes) in discrete streams instead of a Schrödinger cloud, according to the illustration above.  And cathodes, anodes, and years do not matter (based on the From half).

Unfortunately, Nanox own facilitator and option holder testifies that nobody wanted that non-existent digital X-ray source.  Not even when the current CEO, then the Chief Strategy Officer of Nanox predecessor, went to RSNA 2015 to show it around.  Now the title of his blog is IMAGING 3.0 which is remarkably similar to Imaging3.  Coincidence or Freudian slip?  No way he did not know about Imaging3.

  

To the best of Nanox knowledge

Nanox (and predecessor) "first" press releases are quite amusing - Singapore detector in October 2013, digital 1x1x1 in June 2019, and the field of cones, November 2019.

So, Mr. Masuya, a lawyer and the founder and CEO of Nanox predecessor, says in November 2019:

to the best of our knowledge no company have achieved a commercially stable [cold cathode] source [based on carbon nano tubes] that can be embedded inside a medical imaging system and operate with an acceptable lifespan. 

The problem is that he must have known that Carestream and Micro-X had received clearance for and commercialized their Nano x-ray system with a cold-cathode source based on carbon nano tubes in February 2018.  That source was initially made by XinRay (a Siemens JV now defunct, but see NuRay), and now by Micro-X Ltd.  So much for Nanox "knowledge."  

Micro-X CNT source ( from https://www.aumanufacturing.com.au/micro-xs-carbon-nanotube-x-ray-machine-in-clinical-use )

And where is that Nanox source that can be embedded inside a medical imaging system and operate with an acceptable lifespan?  Or did he mean a cheap underpowered hot-cathode Chinese source not suitable for medical imaging? 

Note:  High current with a maximum emitter current of 130mA for up to 2 seconds per tech page.  Compare to Nanox 11mA "proposed" hand-made "hight [sic]" chart. 

First digital source

 In its "first" press release issued in November 2019,  Nanox says:

Nanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli/Japanese cooperation that has created the world’s first commercial-grade digital X-ray source for real-world medical imaging applications

How do you define digital? Roentgen used a cold-cathode (gas discharge) tube when he discovered X-rays, and so did all commercial X-ray sources until 1913.  Carestream/Micro-X/XinRay got clearance for the mobile x-ray unit that uses CNT tubes in February 2018. 

Crookes tube, source:  https://www.emory.edu/X-RAYS/century_02.htm

 

Update March 31, 2021:  Vatech got clearance for its dental x-ray system that uses a CNT tube (V1-650304) in September 2016.

Why Nanox source is digital

Because it is digitally switched with low voltage (30V+), according to this patent.  But so is any hot-cathode source, with filament voltage as low as 3V, and possibly an extra grid or Wehnelt cup electrode.

Wehnelt cup (source:  Lambtron at Wikipedia)

Update March 24, 2021:  A good slide from a IAEA on grid-controlled tubes use in pulsed fluoroscopy:

How fast can you switch?  A 1984 paper says pulse width down to 19 microseconds (says that at the time, fluoroscopy and CT did not requires pulse widths less than 1 millisecond).  The 120kVp is switched with 3.7kVp at the grid, tube current is 125mA

Update April 6, 2021:  The switching grid, or focusing cup, is negatively biased toward the cathode (filament), at about 1kV (while in a conventional tube, the cup is connected to the filament)