A confused press release by Nanox points to fraud

Yesterday Nanox issued a press release and filed a 6-K about its premarket submission to the FDA for a device called Nanox.Arc.  The press release contradicts numerous claims made by Nanox in the past, and contains at least one red herring.

510(k) means the device is not novel

Nanox had repeatedly claimed in the past that the Nanox.Arc device is novel.  Here is another instance, not covered previously:

Nanox.ARC, in collaboration with its companion cloud-based software Nanox.Cloud, is a novel digital x-ray device intended to provide end-to-end medical imaging services ..., according to Nanox founder and CEO Ran Poliakine.

Here is another:

...to use the Nanox ARC system on site for developing novel early-detection and screening protocols to promote global preventive healthcare practices.

The problem is a that a novel device, by definition, cannot be cleared.  Clearance aka pre-market submission aka 510(k) submission is simply a submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) - definitely not novel.  The FDA explains:  

Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE), and De Novo pathways, as well as a subset of those that are brought to market with 510(k) clearance or Emergency Use Authorization (EUA). Of the thousands of 510(k) clearances every year, the FDA considers only those devices with a breakthrough designation to be novel. In addition, in 2020, we are including first-of-a-kind devices authorized under our EUA authority as novel devices. Novel or innovative does not simply mean “new.” They address an unmet need, or may be safer or more effective than currently available alternatives. For FDA-approved and FDA-cleared medical devices, innovation, and safety are two sides of the same coin.

Nanox has not requested a breakthrough device designation.  The 510(k) submission therefore contradicts the claim that Nanox.Arc is novel.

510(k) confirms the RSNA 2020 demo was illegal

Nanox claims to have demonstrated Nanox.Arc version 2.0 at the "virtual" RSNA 2020 trade show last December.  Today's press release confirms the device had no clearance pending at the time of the demo.  This article explains:

A device that lacks FDA marketing clearance is considered "investigational," and therefore the company cannot promote, advertise or accept orders for it. The FDA considers such activities to be “commercialization of an unapproved device." The FDA does make some exceptions for trade shows, however,... [only if the device] is the subject of a pending 510(k) application. It cannot take orders or be prepared to take orders that might result in contracts for sale for the device unless limited to research or investigational use.”

So, since the submission was announced just yesterday, there was no clearance pending in December, which means the device was marketed illegally in December.

This can't be the first version of the "multi-source" Nanox.Arc

According to Nanox technology webpage, the first version of the multi-source Nanox.Arc looks like this:

That device is completely fake.  It is has no x-ray tube, no x-ray detector, no ability to scan - in fact, it is just a mock-up plus an LED light and a battery.  Version 1.5 on that webpage does not look less fake.

At RSNA 2020, Nanox CEO insisted that the design of the multi-source Nanox.Arc has been finalized (in its version 2) - he was just confused whether the device had 5 or 6 x-ray tubes:

The design was changed again in February 2021 - version 2.5? - and the device had no x-ray tubes or a detector.

The device, even if cleared, is not meant for shipping

The press release states:

We are excited to take this next step in our regulatory process as we move toward future versions of the multi-source Nanox.ARC, which will fulfill current and future contracts with service providers and collaboration agreements and allow us to achieve our global vision.

Apparently, the device, as submitted for clearance, is not meant to be delivered or commercialized.  So, why has then Nanox submitted a pre-market notification, that is 510(k)?  Why hasn't Nanox submitted a device that can actually be used? 

 

Nanox.Arc can scan only one human "body part"

The press release states:

Nanox.ARC is a 3-D tomosynthesis imaging system that produces scans of a human body part.  

Just one "body part?"  Which one?  There aren't many "body parts" that can be properly imaged in the supine or prone position using 3-D tomosynthesis.  None are considered "usually appropriate" by the American College of Radiology Appropriateness Criteria.

The "a" is a subtle change from the "the" on page 62 in the annual report, where Nanox claims:

 

Subject to receiving regulatory clearance, the first version of the multi-source Nanox.ARC that we expect to introduce to the market is expected to be a 3D tomosynthesis imaging system that produces a 3D reconstruction of the scanned human body part...

Not much use for a device that can image only one human body part, even if the device were available for free.  

Tomosynthesis is a failed modality

The press release claims there

 

exists a significant unmet medical need globally for a more accessible and cost-effective medical imaging solution

Presumably, a tomosynthesis device like the proposed Nanox.Arc could meet that need.  However,  tomosynthesis is a failed modality, with possible exception of digital breast tomosynthesis (DBT), which Nanox.Arc cannot do due to its design.  Tomosynthesis (also known as tomography, not to be confused with CT or computed tomography) has existed since the 1930s in one shape or another, but its share (DBT excluded) has been less than 1% of unit shipments of diagnostic x-ray devices in the United States and probably even less in the world (based on a preliminary and unpublished analysis of FDA's x-ray assembler data files).  Yes, it is cheap (maybe 10-20% more expensive than plain old x-ray devices - sometimes just a software update is required), but from diagnostic point of view, it is not much better than taking two or three plain radiographs, and it cannot compete with the "gold standards" such as CT or other non-x-ray technologies.

Nanox.Arc is not designed for easy setup and operation

The press release states:

The system is being designed for easy setup and operation with multiple alternately-switched X-ray tubes arranged around the patient.

However, the RSNA 2020 demo revealed that the device requires an external high-voltage generator.  Also, the annual report states that need for 

potential customers to invest in the required safety infrastructure, including customary X-ray shielding, to allow the Nanox.ARC to be safety operated.

The device, as demoed at RSNA 2020, is slow.  The scan of a simple "body part," a phantom hand, took about 45 seconds.  Imagine holding your breath or lying completely still for 45 seconds to prevent image blurring.

The single-source Nanox.Arc transformed into Nanox.Cart

The press release reiterates:

Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021

But that April clearance was initially supposed to be for the single-source Nanox.Arc (Prospectus, Page 1).  To this date, Nanox has never shown a picture or photo of the "Nanox Cart X-Ray System" anywhere.

Nanox has not developed a commercial-grade digital X-ray source

The press states that Nanox 

is developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications

In other words, it has not developed it yet.  So what x-ray sources are used by Nanox.Arc, the one just submitted for clearance?  All signs point to regular (but poorly crafted) hot-cathode x-ray tubes.  

The press release never mentions any cold-cathode x-ray tubes.  The cold cathode is supposedly the core Nanox innovation, but the CEO is apparently unware that x-rays were discovered in 1895 using a cold-cathode x-ray tube. and that tube was completely driven off the market by the invention of the hot-cathode tube in 1913 by GE. 

Just too good to be true

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

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

 

So, what's wrong with his reasoning?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

This head here has this tube inside

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

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

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

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

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

The Nanox.Cart is the only device submitted clearance

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

How live was RSNA 2020?

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

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

partial snapshot of the live recording, about 8:45 

  

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

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

News in Nanox annual report

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

Material weakness

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

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

Dangling chips 

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

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

 

No working Nanox.Arc

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

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

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

No ceramic tubes

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

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

Fuji is out

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

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

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

Chinese tubes 

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

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

 

A confused FDA: Cart or Arc

 

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

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

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

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

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

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.

An early easter egg

Nanox removed the link to its Mammography white paper from its webpage sometime in January 2021 (the paper was first published in late November 2020 in the company's RSNA 2020 virtual booth, and then a link to it was posted on the front webpage in December 2020).  There must be something very important there for Nanox to remove it. 

Maybe it is this:

The first application for [Nanox novel x-ray source] technology is breast tomosynthesis using Nanox’s small X-ray sources in an arrayed series.

Proposed stationary array head (design concept)

Doesn't look much like the multi-source Nanox.Arc, which is supposed to be the first commercial device using the proposed Nanox source, does it?

The paper itself is self-contradictory.  It claims on page 14 that the scan time of one 3D image in present breast tomosynthesis is 15 seconds - moving tube between shots.  But on page 17, the paper admits that the gantry of the 10-year old Hologic machine takes only a total of 4 seconds for the scan (this old intro confirms it).

Why is this important?  Fujifilm, the first potential licensee for Nanox source (see page 88 and II-3 in this registration statement), declined to license the technology when its rights expired in June 2020, but Nanox insists that Fujifilm is still its strategic shareholder and a Mammography OEM (presentation slides 3 and 35 from JP Morgan conference in January 2021).  Nanox also told the press in March 2020 that its Nanox.Arc can perform no-squish mammography, which, of course, it can't (not even in theory):

It could perform tests such as ... a no-squish mammogram for women.

More later.

Update March 31, 2021:  Nanox promoters insist that Fujifilm invested in Nanox.  According to Nanox draft registration statement filings with the SEC, that is not really correct.  For example, the December 2019 filing states that in May 2019, Nanox Gibraltar (that is not Nanox, but its predecessor) issued 1,583,710 ordinary shares to FUJIFILM Corporation for an aggregate purchase price of approximately $3.5 million, and in exchange FUJIFILM was granted a right to first negotiation for license - a right that FUJIFILM declined to exercise and it expired.  A draft filed in August 2020 mentions the same number of shares, but the prospectuses filed in August 2020 and February 2021 do not mention any Fuji shares.  It is rather strange that the number of shares remained the same between December 2019 and August 2020, as a January 2020 press release by Nanox implied that Fujifilm participated in another funding round.

Foxconn is joining Fujifilm, SK Telecom, and other private investors, who have previously invested in the project, as part of a round that is aimed to support Nanox’s development, commercialization, and deployment of its Nanox System.

The press release, issued just before the supposed submission for FDA clearance, is also remarkable because it proves that the Nanox device (presumably, the multi-source one) cannot be cleared. 

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

Novel devices, by the dictionary definition, are obviously not substantially equivalent to any device on the market. 

Update April 12, 2021:  Nanox promoters continue to insist that Fujifilm invested in Nanox, citing a crunchbase entry about the Series B round.   However, it appears crunchbase simply misread the tricky Nanox press release.  

Foxconn is joining Fujifilm, SK Telecom, and other private investors, who have previously invested in the project, as part of a round that is aimed to support Nanox’s development, commercialization, and deployment of its Nanox System.

See, the press release never states that Fujifilm invested or is about to invest in Nanox.  It says that Fujifilm invested in "the project" (that is, Nanox Gibraltar, a Nanox predecessor).  And it does not say that Fujifilm is participating in this round.  In any case, all subsequent SEC filings confirm that Fujifilm did not invest in Nanox - either in that round or thereafter.  As confirmed by the recent annual report, Fujifilm is neither a strategic investor in Nanox nor a Mammography OEM for Nanox, contrary to all investor presentations. 

see, for example, page 3 and 35 in January 2021 presentation at JPM conf.

How does the device look like?

Nanox website, investor presentations, social media, press releases and promo pieces are all littered with designs and photos of various versions of the fancy but fake multi-source Nanox.ARCs.  But you will never find the single-source device that Nanox claims to have submitted for FDA clearance in January 2020.  Not once.

So, how do we know for sure what the device is supposed to look like?  Is it the ugly one that supposedly took the radiograph of the CEO's hand at RSNA 2020 or some fancy multi-source one with just one tube activated?   Has Nanox ever stated, in writing, how the device looks like?

Yes.  A presentation slide helps here - this one, Slide 22, is taken from the January 2021 JP Morgan presentation deck.

It states:

On the left the hand of Ran Poliakine, Nanox s CEO, as was taken during the 2020 RSNA live demo, using the Nanox single source device with the Nanox tube;

So the ugly device from the RSNA 2020 live demo is indeed the device Nanox claims to have submitted for FDA clearance. 

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

Quick credibility check

It is easy to spot that Nanox' management is not familiar with this simple thing called the truth.  Here is a quick example.  Today's press release announces:

With [the RSNA 2020] demonstration, we brought X-ray technology, which had not seen material technological advancements since its discovery more than 120 years ago, into the 21st century.

But Nanox own technology white paper states:

Modern X-ray and the evolution of radiologic modalities started in 1913 by introducing tungsten filament to the cathode part of the “Coolidge” tube, which supplied far better reliability than the preceding technologies. Over a hundred years later, X-rays continue to be generated by electrons supplied by heating tungsten filaments. The history of radiology is the history of the “Hot Cathode” invented by Mr. Coolidge.

1913, by the way, was just 108 years ago.  And X-rays were discovered in 1895, according to the same paper.

So, which one is it?    Did X-ray technology see a material technological advance after the discovery of X-rays but prior to RSNA 2020, or not?  The white paper says, yes, in 1913, when the hot-cathode technology introduced by GE completely obliterated the cold-cathode technology that Roentgen used and that Nanox now pretends to use.  The press release says no way!  Which one (press release or white paper) should we believe?   Which one (Coolidge or Poliakine) advanced X-ray technology?

Update:  By the way, Nanox cannot say that this is a simple mistake or misunderstanding, as Nanox claims that the Chair of its Advisory Board is Morry Blumenfeld, who was a GE employee.

You can't have it both ways

Even the best artists (scam artists included) slip sometimes - they are human, after all.  Let's take a listen to what the CEO has to say in the Nanox "vision" video released in late November ahead of RSNA 2020:

"Our mission is to democratize medical imaging, to make it way more available.  There are simply not enough machines today - it is too expensive - expensive to buy, expensive to maintain, expensive to operate, and therefore not very practical." (starting at 47s)

So, medical imaging  is not practical and accessible today?  

Here is what he wrote in his March 30, 2020 blog post:

In Israel, as in practically every country in the world, we have a real shortage of [COVID-19] testing kits.  Lung scans on the other hand are accessible, cheap, and the results are immediate - a critical factor in patient outcomes and in preventing the spread of the infection.

He can't have it both ways.  Chest (or lung) radiographs represent the majority, about 40%, of all imaging procedures performed worldwide, according to the World Health Organization (Communicating Radiation Risks in Paediatric Imaging, page 16).  The CEO states that they are accessible, cheap, and with immediate results in practically every country in the world.  So, it seems there are enough medical imaging machines, they are not expensive, and they are easy to operate and quite practical, no?  Poof goes Nanox vision!

In his blog post, he also states that Nanox machines

can be installed not only in medical facilities but also in offices and even retail locations, so people don’t need to drive hours to get to a scanning machine.

But Nanox now admits that is not possible - Nanox proposed machines leak radiation - and any potential deployments of those proposed machines, in the unlikely event that they ever become real, is at risk due to:

the inability or unwillingness of potential customers to invest in the required safety infrastructure, including customary X-ray shielding, to allow the Nanox.ARC to be safety[sic] operated (page 17, prospectus)

 

Asking stupid questions

So, a stupid question arose today in a discussion about what would be a plausible defense by a scam artist.

Question: Did Nanox CEO graduate from Bezalel Academy of Art and Design, or not?

Checking English-language internet sources left me confused.  This one says he only attended the Academy, that is, he did not graduate.  Another one says he received a Degree in Industrial Design there.

In a November 2020 blog post, the CEO states:

When I submit my bio (prior to lectures or interviews), my educational background often surprises people. I do not have a degree in machine engineering, computer engineering, or in any type of engineering for that matter. I studied arts and design at the Bezalel Academy of Arts in Jerusalem.

So, he did not graduate, after all?

According to a Muddy Waters report,

Charismatic CEO Poliakine appears to have no formal training in radiology, physics or medicine—or to have even finished college. His only academic credentials seem to be a two-year stint he spent at the Bezalel Academy of Arts and Design. Our investigators contacted a Bezalel administrator who confirmed that he did not graduate (page 42)

In his blog post he essentially describes himself as a modern Leonardo Da Vinci, "the great artist and innovator," but with the inclination to ask stupid questions:

This is something I do all the time: go into new areas and ask stupid questions. I have no choice: I am not an established scientist or a researcher with formal education. So I go in and ask the kind of questions that people who’ve been in this field for a while would not consider asking. 

Essentially, he is paraphrasing Meredith Perry of the fraud uBeam (now, SonicEnergy).  The problem in the real world, of course, is that if people take time to answer all the stupid questions, there is no time left for anything else.

It is a great defense, though  - I did not know what I was signing or talking about - I am an artist.  And an artist is allowed to pretend to be something more:

I am a technologist. I want to tell you about the technology of Nanox... (02:05 in the RSNA 2020 demo)

 

And then to lie outright that Wilhelm Roentgen used a hot filament to discover X-rays (Nanox own technology white paper, published just a few days prior, states that the hot filament was introduced by GE's Coolidge, many years after Roentgen's discovery)... 

The dictionary seems to define technologist as an expert in a particular field of technology, not just an artist.

Planned spontaneity

There are two reasons why the scan of the CEO's hand at RSNA 2020 was not spontaneous as he pretended.

Reason 1:  About 9:20 into video the DICOM tag displayed on top of the radiograph says "Ran_3" - meaning, this was the third time they tried this (the CEO's name is Ran, of course).

Reason 2:  The video overlay with the CEO's name comparing his hand with the hand of Roentgen's wife was prepared well in advance.  It appears briefly in a frame before his radiograph actually shows on the display at about 8:06 into the video.

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.