How SK Telecom promotes its investment

If the lie is big enough, and if you repeat it, maybe people will start believing it.

Someone posted a link to the June 2020 press release by SK Telecom as a proof that Nanox is not a fraud.

The press release states:

Nanox developed the innovative Nanox System, which is composed of the Nanox.Arc, a novel digital X-ray device.

Oops.  Novel!  Apparently, nobody told SK Telecom that a novel X-ray device cannot be cleared by the FDA, because clearance requires a substantial equivalence to an already legally marketed device.  So being  novel, the device is clearly (pun intended!) not equivalent to anything on the market already, and so cannot obtain a 510(k) clearance. 

So, if SK Telecom did not lie about the novel thing, then Nanox regulatory strategy goes poof.  Because Nanox has been telling investors that it plans to 

submit an additional 510(k) application with respect to the multi-source Nanox.ARC, which, if cleared, will be our commercial imaging system

 

But how exactly is Nanox device novel?  Well, it is fake and non-functional.  That's its novelty.  The press release helpfully supplies its picture.

Only for angels (humans too heavy for this "body scanner") 

The table clearly can't support a human being.  The Arc is immobile and cannot move along the table (even though it is labeled BODY SCANNER on the side).  The whole thing is powered by a 12V battery (to light up a few LEDs for the photographer and the greedy investors and advisors).  There are no functioning x-ray sources or detectors in the device.  Nanox says on its tech webpage that this is version 1.0 of the device, and claims:

Cold cathode tubes allow the use of a single high voltage power supply and a ‎single high voltage supply line (connecting all the anodes in the system). Digitally ‎controlling each tube enables the system to be significantly reduced and saves ‎power supply cables, installation space, and so on.‎ ‍

Which could be true, indeed, if 12V is high voltage, if and those cold cathode tubes do not generate x-rays but simply multi-spectral light.

The press release also shows an animation gif of the levitating scan, that must generate antigravitons.  Nanox has not provided information as to which version of Nanox.Arc that is.

Roentgen discovered X-rays in 1895, Nanox discovered levitation in 2019.

Update:  Apparently at least one radiologist agrees about Nanox.Arc.

Nanox chances for FDA clearance are dimming

Nanox claims to have submitted its official response to an accredited Review Organization under the FDA 510(k) Third Party Review Program as part of the company’s 510(k) application process for a single-source version of the Nanox.ARC on September 3, 2020.  That single-source version of the Nanox.ARC is the ugly plain x-ray "machine" shown here.

Assuming the Review Organization ("Third Party") took a month, instead of a day, to read that response and recommend the device for clearance to the FDA, when should investors expect news of a 510(k) clearance?

If Nanox responses were satisfactory, the Third Party should have submitted its recommendation to the FDA by October 3, 2020, and the FDA should have cleared the device within 30 days, or by November 3, 2020. We are now at day 97.  What is happening?

Well, while the FDA review timeframe is within a month, that doesn't always happen, for various reasons, including the FDA asking for more information. 

Here is the histogram of all clearances of diagnostic x-ray systems (including tomo and mammo, but excluding dental) done through a Third Party since 1999. 

Histogram of x-ray diagnostic clearances through a Third Party
source:  FDA 510(k) database

Of the 179 clearances, only 10, or 6%, have occurred past day 97 since 1999.

Worse, of the 10 clearances in the past 5 years, none have occurred past day 86.  All of the four successful clearances submitted in 2020 (submitted in April-November) were done within 22-26 days.

Oops.

Note:  There are reasons to believe that Nanox never submitted for clearance anything, either directly to the FDA or through the Third Party Review Program,  or if it did, the submission was likely fraudulent.

Note 2:  If anyone is wondering what was that outlier device that took almost a year after the Third Party recommendation to get cleared, here it is. A simple wireless controller for an x-ray system.  It actually took 550 days since the company had submitted to the Third Party.  That Third Party is no longer participating in the FDA program, by the way, and it is not clear whether the company is still in business (last website update in 2019?).

Note 3 (added January 22, 2021):  It appears Nanox is confused about how its single-source source device looks like.  Here is a fancy-looking one (from a presentation slide at a JP Morgan conference), not the ugly one presented at RSNA 2020 in December 2020.  If Nanox is confused, think about how confused the Third Party and the FDA must be (assuming Nanox ever submitted anything for clearance, of course)!

Note 4 (added January 27, 2021):  An avid reader of this blog,  @Midas touch on Youtube, has remarked:

[RichardXRoe's] "perspective" is at best biased. Please don't throw allegations around without any sources - you will get sued for such false statements without providing proof.

E.g your claim that the external company answered within 1-30 days and sent it to the FDA and that the approval is now delayed. How would you know how long it took the external company to respond? If you make such drastic claims like "it's" a fraud you simply must provide evidence. I am more than happy to look at a different angle if you would present it. I assume you probably started shorting below $40 and I am sorry for you, but these statements will just bring you more trouble.

And here is my response:

First of all, there is no external company and no approval in the 510(k) Third Party Review Program.  There is a Third Party and a recommendation.  If that recommendation is "substantially equivalent," then the FDA has 30 days, by statute, to clear the device or not, as already explained.  The Third Party does not answer.

Second of all, there are now reasons to believe that Nanox never submitted anything for clearance to anyone ever, or, if it did, it did so fraudulently (see, for example, Note 3 above).  

So, of course, I have never claimed that the external company answered something within some days, sent something to somebody, and the approval is now delayed.

What I do claim is that, according to Nanox, the Third Party received a reply to its additional information request on September 3, 2020.  The response, according to Nanox,  included additional data and other information to complete the application and to address certain deficiencies highlighted by the reviewer, including the results of certain performance tests, and was submitted within the required time frame.  So it is reasonable to assume that the Third Party, after waiting for six months, read the reply on the same day.  It is also reasonable to assume that the Third Party, being busy and such, waited a few more days and submitted its recommendation (substantially equivalent or not substantially equivalent) to the FDA within a month.  The rest is history.  That is, the history of the 510(k) Third Party Review Program shows that the chances of clearance for Nanox have now dimmed, assuming that Nanox ever submitted anything for clearance to anyone to begin with.  And that is trouble.

Note 5 (January 28, 2021):  I just saw that the 6K filing announcing the supposed response incorrectly characterizes the equivalence claim.  

The submission was based on a predicate filing for an equivalence claim to an existing FDA-approved X-ray imaging system by another market participant, and no new claims were made as to the operation, image quality or functionality of the Nanox.ARC versus the predicate device.

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device, not to an existing FDA-approved X-ray imaging system.  Most x-ray imaging systems are FDA-cleared, and very few are FDA-approved. All of those approvals are over 5-year-old (a search for "tomo" in the PMA database shows the latest original device was in April 2015, for example), and therefore are not good predicates.  Why did Nanox mis-characterize the equivalence requirement?  The device that Nanox has supposedly submitted is a simple x-ray device - why would its predicate require any approval (like say a breast tomosynthesis device would 10 years ago)?

Note 6 (January 29, 2021):  A question was posed on Seeking Alpha:  If the device were fake, why did Nanox submit for clearance?  And the answer (heavily paraphrased) is:  Well, without the promise of clearance or approval or grant, Nanox has nothing (since so far no one is interested in its x-ray cold cathode or source, an exempt device that does not require clearance, after 5+ years of heavy marketing).  I have reasons to believe that the company never submitted anything to anyone for clearance. But let's assume for a moment that the company did indeed submit a device for clearance through the Third Party Review Program, as the company says. Well, the Third Party may have already recommended to the FDA not to clear the device (that is, an NSE recommendation).  How would one know, since it is not public information?  Why would Nanox tell the public the truth, if it did not tell the truth to begin with?  Maybe Nanox has already withdrawn or abandoned its submission - no way to know without a FOIA request that the FDA says it can take a year.  And about that device:  Nanox stated in a draft registration statement filed with the SEC in early February 2020 that the device was NOT WORKING when submitted for clearance in January 2020, which sounds like fraud (unless it was an "honest" mistake or mixup, of course):

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

Moreover, see also Note 3 above.

Note 7 (January 30, 2021):   There is a theory on StockTwits that somehow COVID-19 has disrupted and delayed the clearance process through the Third Party Review Program.  That is completely untrue, and it makes no sense - in fact, FDA issued a special guidance to expand availability and capability of x-ray systems since they have been used for COVID-19 diagnostics.  As already pointed out above, all the four clearances in 2020 were done within less than 30 days.  Micro-C, the only x-ray clearance through a Third Party so far in 2021, was also done within 30 days (although that device's clearance had been "pending" and "imminent,"  whatever those mean, since 2018, see also here) 

Note 8 (February 2, 2021):  The company filed this gem with the SEC yesterday.  So it appears the FDA has requested additional information.  The good news is that Nanox did submit something to someone at some point.  The bad news is that the submission may have been fraudulent, as the FDA is asking about intended use and predicate.

Note 9 (February 9, 2021): Nanox now changes its story.  Nanox now says that Third Party was not entirely happy with Nanox response, but at the end recommended the submission for clearance on December 28, 2020

In the United States, we are taking a multi-step approach to the regulatory clearance process. As a first step, we submitted a 510(k) premarket notification for a single-source version of the Nanox.ARC to an accredited Review Organization under the Third Party Review Program in January 2020. As part of the review process, in March 2020, we received an information request, referred to as a major deficiency letter [no such thing in the 510k process, but ok], from the Review Organization, which among other things, required us to provide additional data and other information to complete the application and to address certain deficiencies highlighted by the reviewer, including the results of certain performance tests. On September 3, 2020, we submitted our response to the Review Organization. The response included additional data and other information to complete the application and to address certain deficiencies identified by the reviewer, including the results of certain performance tests. On September 10, 2020, the Review Organization requested that we include a second predicate device in our 510(k) premarket notification [ oops, a second predicate!?! and Nanox proved substantial equivalence to it in 16 days, wow! ] . On September 26, 2020, we submitted our revised 510(k) premarket notification to the Review Organization, which the Review Organization subsequently recommended to the FDA for clearance on December 28, 2020. On January 1, 2021, we received an information request from the FDA through the Review Organization regarding our submission, which we responded to on January 4, 2021. 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 plan to respond to these requests promptly. In addition, we will continue to work to address further information requests, if any.

So, since Nanox now says the clock started on December 28, 2020, we are now  43 days into the 30-day  process, giving a 15% chance of clearance, using the entire history since 1999.

Note 10 (March 11, 2021):  Wrote a blog post about what was supposed to happen, if Nanox did not lie to investors about the status of its FDA submission, if there was any, of course.

Update March 11, 2021: Fixed the Notes numbering.

Update April 5, 2021:  Nanox beat the odds and got clearance for a Nanox.Cart (an ugly single-source device).

These are the facts

Ugly
source:  RSNA2020 live demo

1. Nanox has not submitted anything for FDA approval.
   
   
2. It is illegal to market a Class II MEDICAL device, such as an x-ray diagnostic system, in the United States without clearance (or De Novo grant) pending (there are limited exceptions, but they don't apply here).
   
   
3. Nanox now claims to have submitted an x-ray system for FDA clearance in January 2020 and that it does not intend to ever market that system. That "system" is very ugly, and is completely different from what Nanox has been showing in its investor presentations. The one shown in investor presentations has not been submitted for clearance, approval, or De Novo grant. There are reasons to believe that Nanox did not submit anything for clearance in January 2020, or, if a submission happened, it was fraudulent.

These are the facts. They are indisputable.

Fake (notice the XANON label)
source:  November 2020 Investor Presentation, Slide 3 

Update April 5, 2021:  Nanox got clearance, not approval, for a Nanox.Cart (the ugly device).

Random youtube comments

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

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


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

Added January 12, 2021:

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

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

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

Added January 21, 2021:

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

Added January 22. 2021:

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

More (youtube and elsewhere):

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

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

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

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

Opinions by opinion leaders

Money blinds and corrupts.  It makes some radiologists say stupid or untrue things.

 

So, here they are, in order of appearance.

Dr. Pelc

The father of modern radiology, according to some, says that hot cathodes were invented by Coolidge in 1917.  Nanox own tech white paper says that happened in 1913.  Who are we to believe?

Dr. Dawson

A top British radiologist praises "nano tubules," failing to realize that there are no such "tubules" in the fake Nanox source, which was supposed to use brilliant "nano cones" instead of the crappy CNTs.

Dr. Samei

A top academic radiologist claims that Nanox technology provides us the opportunity "to move the source in two directions." ONLY in two directions?  Maybe, if the source is fake.  Of course, in the real world, the source can be moved in nearly infinite number of directions.

Dr. Rubin

Another top academic radiologist says that a cold-cathode tube, like the one used by Roentgen, does not generate the same level of heat as a hot-cathode tube.  We need to cool the cathode then?  The fact is that nearly 100% of the heat in any decent hot-cathode x-ray tube is generated in the anode.  

He also insists that no one dare consider adding three sources, four sources, or even more [in a CT imaging system].  What did he do while attending RSNA 2019?  How come he missed that one exhibiting company dares considering 16 to 24 sources?  Maybe because the Chinese NanoVision did not pay him, while the Israeli Nanox.Vision did.

updated: January 22, 2021

Update April 30, 2021:   Dr. Pelc was on the Advisory Board of Theranos, the fraud.  He is also on the board of Izotropic, an obvious scam (a copycat of Koning).  He is the winner of the 2013 RSNA Outstanding Researcher award and many still consider him a credible authority in the field.

Nanox "live" tomosynthesis looks suspect

The Nanox.Arc tomosynthesis demoed at RSNA2020 looks fake. 

It was likely prepared in advance elsewhere.  Inspecting the image orientation of DICOM thumbnails shows a 180° mismatch for the lamb femur in the reconstructed image:

 

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. 

A cautionary tale

The Dominion Volumetric Imaging Scanner by Imaging3 was supposed to be the first ever system that could produce a combination of 2D, 3D, and CT imagery in a single device, including live stream (fluorosocopy) - high quality 2D images in Continuous 2D Scan mode, high quality 3D images in Continuous 3D Scan mode, and Single 3D SafeScan mode.  The unique engineering design accomplished these capabilities while dramatically reducing exposure to radiation, and providing a small, mobile footprint for easy transport, all at a cost of about one third of existing CT devices.

Sounds and looks familiar?

It was all a scam.  

Here is the FDA rejection letter.  Some more details here, and the SEC complaint.

image source:  www.imaging3.com

Thanks to Fleipeg on Seeking Alpha for bringing it to my attention.

Puzzles

This was Nanox.Arc version 1.5, per tech page.

   

The device is obviously non-functional, despite the 11 glass tubes drawn in it.  It is mechanically unstable, so no actual person can be scanned (it will simply tilt over, if somebody tries to sit on it!).  The detectors themselves, if there are any in the table (because there are none in the arc), will cost at least $500,000.

source:  front-page video titled "Understanding Nanox technology & vision" (vimeo ID 393211389)

Note:  Slight change in the design of the Arc in the video - is that Arc 1.4 or 1.6?

Reference list

Photon-counting CT:

Photon-counting CT: Technical Principles and Clinical Prospects, 2018, Pelc etc  

Photon-counting Detector CT: System Design and Clinical Applications of an Emerging Technology, 2019 (EID is the conventional energy integrating detector)

Cold cathode:

Advances in cold cathode physics and technology, 1999 old, Israeli

Fuji S-value:

Investigation into Factors Influencing Fuji S-Value Using an Extremity Phantom, 2011

The standardized exposure index for digital radiography: an opportunity for optimization of radiation dose to the pediatric population, 2011

HVL:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-major-components-21cfr-102030-102031-102032 (21 CFR 1020.30(m), Table 1, over 1.3mm above 51kVp)

IEC 60601-1-3, Table 3 , HVL is 2.0mm for 55kV ( per 2013 edition) / IEC 60601-1-3 is referenced by IEC 60601-2-54 which is in FDA's Recognized Consensus Standards for mobile x-ray systems.

Benefits of Tomo:

Digital Tomosynthesis to Evaluate Fracture Healing: Prospective Comparison With Radiography and CT, 2015

Tomosynthesis:

https://github.com/LAVI-USP/DBT-Reconstruction

accompanying paper with 9 projections, 1mm or 0.1mm detector pixel, compares to Senographe Essential (PMA)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2832060/ 

         a 2009 paper that was still hopeful about tomosynthesis.

Intro for technologists (Hologic, Siemens, projections, seconds, algorithms, slabs, screening?)

Tube current exposure time product (mAs):

https://www.upstate.edu/radiology/education/rsna/radiography/mas.php

CNT XinRay, etc:

https://www.aapm.org/meetings/amos2/pdf/42-11909-37935-43.pdf , 2009, when things looked promising.

Field Emission Displays

The unpublished history of FED, up to Sony.

Predecessor datasheets

November 2015. ; January 2016

FDA:

https://www.mobihealthnews.com/news/commentary-digital-health-companies-should-stay-away-fda-2021 some interesting points re current state of De Novo affairs

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals , 2017 (tells what happens if the submitter simply does not respond fully to a request that would self-incriminate it - deletion/withdrawal). 

COVID-related impact Q&A December 2020, and other guidance.

Third Party guidance March 2020 - steps/clocks/terminology such as "early interaction," "review memorandum," "review documentation," "cover letter, " "role of a consultant," "rerecognition."

The 3P510k Review Organization should send to FDA via e-mail to 3P510K@fda.hhs.gov information on any complaint (e.g., whistleblowing) it receives about a 510(k) Submitter that could indicate an issue related to the safety or effectiveness of a medical device or a public health risk. 

Section 523(b)(3)(F)(iv) requires 3P510k Review Organizations to agree that they will promptly respond and attempt to resolve complaints regarding its activities for which it is accredited. FDA recommends that 3P510k Review Organizations establish a recordkeeping system for tracking the submission of those complaints and how those complaints were resolved, or attempted to be resolved.

Guidance if the 510k submitter chooses to utilize standards.

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals , 2017

An order declaring a device to be NSE (NSE letter) is a letter issued to a 510(k) submitter stating that FDA has determined that the device described in the 510(k) submission is not substantially equivalent to any legally marketed device and may not be introduced into commercial distribution in the U.S

the device has a new intended use compared to the identified predicate device;

Found this submission guide useful (e.g., summary gets published within 30 days)

510(k): substantial equivalence , format, content, foreign tests, clinical data.

CE Marking:

MDR

The Medical Devices Regulation - Where Are We Now?:  The new MDR now requires total life cycle traceability between all stages of product development and post-market activities. General safety and performance requirements (GSPR) checklists have been mandated.  Clinical evidence is now required for all medical devices. //  The MDCG on Clinical Investigation and Evaluation released four guidance documents on 23 April 2020 to assist with some of the key clinical requirements outlined in the Medical Device Regulation (MDR). The documents include Guidance on Clinical Evaluation – Equivalence, Guidance on Sufficient Clinical Evidence for Legacy Devices, PMCF Evaluation Report and Guidance on PMCF Plan Template.

Updated: October 7, 2021

The mystery CT machine

What was the mystery device behind Nanox CEO back during the RSNA 2020 demo?

I think it is a Canon/Toshiba Aquilion CT model, with a tilting gantry.  But the current AuntMinnie consensus is that it looks like an inflatable mockup, just like the company itself.

 

Full-body scan vision

According to Nanox CEO, 

"Nanox.Arc could provide a full-body digital X-ray scan ... Most, if not all, cancers can be treated rather easily if found early enough through medical imaging. The World Health Organization says if every person had a full-body scan once a year, potentially millions could be saved by early detection." (Israel21c, March 23, 2020)

The problem is that the World Health Organization never said that.  In fact, it said exactly the opposite:

Whole body CT for IHA [individual health assessment] of asymptomatic individuals should cease.

Nanox vision is based on a lie.  

Nanox has backtracked since - now it is early detection of SYMPTOMATIC PATIENTS only!

Here is what the American Academy of Family Physicians says:

"Whole-body scanning is not recommended by medical professional societies for individuals without symptoms, nor is it a routinely practiced screening procedure in healthy populations."

Choosing Wisely, an initiative of the American Board of Internal Medicine, in cooperation with Consumer Reports and American and American College of Preventive Medicine has this to say about whole-body scans:

 "They don’t help find cancer—and may do more harm than good... No medical societies recommend whole-body scans. That’s because there is no evidence that the scans are a good screening tool.  Whole-body scans can lead to unnecessary follow-up tests."

Further reading:

Radiation Risk From CT: Implications for Cancer Screening, Jeffrey M. Albert

The available data suggest a small but real risk of radiation-induced malignancy from CT that could become significant at the population level with widespread use of CT-based screening. However, a growing body of literature suggests that the benefits of CT screening for lung cancer in high-risk patients and CT colonography for colorectal cancer may significantly outweigh the radiation risk. Future studies evaluating the benefits of CT screening should continue to consider potential radiation risks.

See also CT Radiation Dose and Risk: Fact vs Fiction 

 technologists also must consider the risks of reducing dose to the point that image quality falters or diagnoses are delayed or missed.

Average doses.

Pro mammo screening.

On mammograms and AI, rather than full-body, but article wrong about tomo for screening (note: Nanox.Arc can't do mammograms, compare to no squish, January 29, 2021):

More-aggressive screening strategies aim to maximize the benefits of early detection, whereas less-frequent screenings aim to reduce false positives, anxiety, and costs for those who will never even develop breast cancer.

“We know MRI can catch cancers earlier than mammography, and that earlier detection improves patient outcomes,” says Yala. “But for patients at low risk of cancer, the risk of false-positives can outweigh the benefits. With improved risk models, we can design more nuanced risk-screening guidelines that offer more sensitive screening, like MRI, to patients who will develop cancer, to get better outcomes while reducing unnecessary screening and over-treatment for the rest.”