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."  

Another confirmation that Nanox.Arc is fake

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

 

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

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

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

More later.

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.

Cost confusion

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

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

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

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

But Slide 41 in the January 2021 presentation says:

Costs tens of thousands of dollars

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

Neither.

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

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

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

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

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

The production Nanox.Arc has no detector?

So John Nosta puts a tweet out that shows that Nanox.Arc has no detector, and therefore, cannot make any images.  Stock goes up 15%.

Here is the fake, non-functional device that (supposedly) goes into production, with no clearance or any regulatory approval pending, in all its glory:

John Nosta is the same evangelist who in August 2019 posted the photo of the completely-fake 12V-battery-operated Nanox.Arc 1.0 that could emit electromagnetic waves, but only in the visible spectrum.  According to Nosta, it could fit in a suitcase (it must be a gigantic suitcase!)  and would emit "lower" radiation (which is correct, as visible light is lower in the energy spectrum than x-rays, but can't penetrate most human organs and is therefore useless for diagnostic purposes).  

Update:  In case it is not clear, here is where the detector goes in Nanox.Arc 2.0 (which is the finalized production-ready design, per CEO investor presentation post RSNA 2020 demo).

Cropped snapshot from the Making of Nanox Arc video 

Update:  Added zoomed view of Nanox.Streak and Nanox.Thread:

Update:  Apparently some people are confused where this picture was taken, and believe it is at Foxconn, where the volume production was initially supposed to take place.  The picture was taken in Israel, however (notice the green EXIT sign above the door in Hebrew יְצִיאָה - thanks google translate!).  

Due, in part, to travel restrictions as a result of the COVID-19 pandemic, we expect to manufacture a small number of Nanox.ARC units in Israel on a purchase order basis that will be used for the acceptance tests under our MSaaS agreements, demonstrations, regulatory approvals and for the initial global deployment, among other purposes. (page 5, prospectus)

Update:  Added a link to Nosta's August 2019 tweet and a few words about it.

Update:  Ok, ok, this could be the detector.  Added a question mark to the title of this post...

Update April 21, 2021:  Based on inspection of the latest Nanox video, the device in Nosta's tweet has no detector.  What looked like a possible detector in the view from this angle is likely just a part of the support frame.

zoomed-in snapshot from the new video

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.

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?