Fooling greedy foreigners is so easy

Nanox Chairman (and soon to be former CEO) lies to the Korean press again, inflating chip production estimates by 30x in the temporary "plant" and by 9x in the future "fab:"

The Cheongju plant has a partial production capacity of 300 wafers per month, and can produce 50-150 chips per wafer depending on the product line. Chairman Poliakine added, “The clean room size for semiconductor production will also be expanded to more than three times that of the Cheongju plant.” [google translated]

His statement contradicts the slides from the investment presentation at Jefferies on June 4.

Specifically, the temporary "clean room," which is not clean at all and located in an equipment parts manufacturing plant, was supposed to have a maximum capacity of 1,000 chips per month, not the 15,000-45,000 (300 x 50-150) he told the Korean press.  Similarly, he lied about the new fab, when he said production will be more than 3x, implying over 45,000-135,000 chips a month, while the investor presentation said 10,000 chips a month at full capacity.

Weren't Koreans supposed to be good at math?

By the way, those chips are neither semiconductor (they are supposed to use small molybdenum pins, not semiconductors) nor MEMS (there is nothing mechanical about them), and they are not functional.  Here is a snapshot again from the August Business Update proving that the temporary "clean room" is not clean at all, showing the chips all covered with dust specs everywhere.

The article also repeats the lies perpetuated by Nanox investor, Yozma group:

Nanox is a company that manufactures X-rays that can reduce radiation exposure time by one-half by shooting images with clearer quality than existing X-rays at 30 times faster. Its size and weight are one-fifth of that of existing devices, so it can be used in small hospitals and medical blind spots. 

All of the statements in the paragraph above are intentionally misleading.  As the 510(k) summary revealed, Nanox' tube is nothing more than an used and abused (and severely underperforming) dental x-ray tube that is underpowered and slow.  Nanox proposed devices are obviously larger than the portable x-ray devices that it underperforms.

A handheld x-ray device by Vatech Korea

Update:  A slightly different version of the same article also quotes the upcoming CEO, who was kicked out of his Chairman position at Hadassah Medical Center last year (he was also on the Board of Nanox when Nanox signed a suspect agreement with Hadassah):

New CEO Erez Meltzer said, “Once the acquisition of Zebra Medical is completed, we can create next-generation medical devices with imaging AI solutions. Zebra's AI and cloud can form a new AI-assisted diagnostic space," he said. "New cooperation opportunities are always welcome."

The new CEO will not be much different from the old CEO, based on the statement above.  Zebra's AI simply does not work with the proposed Nanox.Arc - the reason is simple - Zebra's AI has been trained on regular x-ray images, while there is nothing regular about the proposed Nanox.Arc.  For example, the chest images that Zebra has utilized must be standard standing/sitting erect PA at a sufficient distance from the x-ray source, while all the proposed Nanox.Arc can produce is an underexposed, close-range supine AP (and it is a good bet Zebra has no chest tomosynthesis training images whatsoever).  Maybe Zebra's team can deliver a miracle, eventually, but only after thousands of the proposed Arcs have been deployed and fully utilized and many, many years.

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).

Still a scam

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

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

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

 

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

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

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

A lie about 1,000 tubes

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

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

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

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

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

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

This head here has this tube inside

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

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

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

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

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

The Nanox.Cart is the only device submitted clearance

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

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.  

The "nano" in Nanox isn't

So, Nanox has been boasting in the technology section on its website: 

Over nine years of development by a Japanese and Israeli engineering team, produced a ‎stable Cold-Cathode field emission MEMS silicon‎. Using proprietary Micro-Electrical-Mechanical-Systems (MEMS) techniques, ‎millions of nanoscale gates are fabricated on each silicon chip. ‎Nanox emitters are far more uniform than carbon nanotubes (CNT) and are orders of ‎magnitude smaller than conventional Spindt-type cathodes‎. ‍

But is any of it true?  For example, has Nanox been able to miniaturize a technology that was a complete failure and make it potentially successful?  The answer is:  No!

If Nanox' emitters are "orders of magnitude smaller" than conventional Spindt-type cathodes, this means they are smaller than 1/100 the size of the "conventional" emitters (that's two orders of magnitude).  Here is how Nanox emitters are supposed to look like under an electron microscope (Slide 13, January 2021 JP Morgan presentation).

They look tiny, but how tiny are they?  Nanox is withholding that information.  Luckily, Nanox predecessor company has already published the original image - in early 2016, in a one-page "Nanox Technology Brochure" - with an embedded scale in it, like any regular image, or micrograph, generated from a commercial electron microscope.  All we have to do is use that scale to measure the diameter of the gate holes and the distance between them, and compare to say state-of-the-art Spindt emitters twenty years ago.

Aha.  So the holes are about 300nm in diameter and the distance between them is about 500nm.

And, what was the state-of-the-art twenty years ago, in year 2001?  Here is a picture from the Motorola paper titled "Field Emission Displays: a critical review" 

Uh-oh.  Turns out the Spindt holes from Candescent Technologies were actually smaller - 100nm in diameter, and intentionally placed at random distances.

Is it possible that somehow Nanox' team did not know about those developments twenty years ago?  Nope.  Here is why.  According to the unofficial history of the Spindt scam,  three years prior, Sony, desperate to maintain its relevance in the TV market, but completely clueless, joined forces with Candescent.

In November 1998, CTC announced an agreement with Sony Corporation for joint development of a 14-inch diagonal FED by the year 2000. Both companies pledged to spend $50 million on this effort. Most of the work would be performed at CTC's plants. A team of six Sony engineers were sent to San Jose to begin the work, with some additional staff dedicated to the project in Japan

Motorola had already canceled its project in 1999, thus the paper in 2001, due to inability to "solve some basic technology problems."  Candescent went bankrupt in 2004.  It took Sony a few more years to realize its mistake, but the $1 billion R&D spending is a complete myth.

So, to reiterate, ‎Nanox emitters are not orders of ‎magnitude smaller than conventional Spindt-type cathodes‎ - they are, in fact, LARGER.  Not that it matters, because Nanox, contrary to the false claims in the Prospectus and elsewhere, has no access to facilities to fabricate them commercially.

And the "nano" should have been a red flag anyway - MEMS in the supposed Nanox "Cold-Cathode field emission MEMS silicon" stands for micro-electro-mechanical systems.  Electro, not electrical.  Micro, not nano.  And there is nothing mechanical (moving) - the "electro-ns" do not count.

Ok, but what about those 100 million emitters in Slide 13 above?  Well, that number is possible.  Assuming those are positioned in a 10,000 x 10,000 square, and assuming 800nm distance between the tips, that gets us to a 8mm x 8mm "chip," ballpark.  But such a chip, even if it were real, is not changing anything.

In case anyone was wondering how big the Spindt emitters were 50 years ago, here is a diagram and a micrograph from the 1976 Spindt paper.  The gate hole diameter is 1,500 nm.  So Nanox emitter is just 1/5 of it, not 1/100.

Update March 29, 2021:  reworded and added the original Spindt emitter size.

Update March 29, 2021:  Wikipedia's page on Field Emitter Arrays have an interesting entry about nano-Spindts.

Nano-Spindt arrays represent an evolution of the traditional Spindt-type emitter. Each individual tip is several orders of magnitude smaller; as a result, gate voltages can be lower, since the distance from tip to gate is reduced. In addition, the current extracted from each individual tip is lower, which should result in improved reliability.

How did this incorrect and misleading entry wind up on wiki?  After checking the edit history, it turns out Nanox added it on December 22, 2015, a few days after the failed attempt by Nanox predecessor to market its fake cathode at RSNA 2015 (Nanox current CEO was then the Chief Strategy Officer).  Here is who added it:

My name is Joshua Lilienstein. I am an American medical doctor, now specializing in medical device development. I currently serve as Chief Medical Officer for Nanox Imaging, Plc., a Japan-based startup. Nanox's core technology is the field effect cathode. I will be editing entries that pertain to this technology, and specifically, in its application to medical imaging. I am aware of Wikipedia's Conflict of Interest policies, and will endeavor to abide by them.

At least he was honest about something.

He referenced an interesting paper that does not support his wiki entry in any way, but describes the long-lost x-ray detector, SAPHIRE, that was supposed to use nano-Spindts.  This is a flashback to the times when Nanox team "believed" that the x-ray detector was more important than the x-ray source.

CT vs Tomo vs Fluoro

I have been having some interesting discussion with Nuno Lemos aka StockZombie @ Twitter, who has compiled his due diligence on Nanox at "Nanox Vision – a fools gold?"  

Here is some feedback on some of his points. 

Can you replicate CT with Tomo?

Nanox has been misleading the public, investors, and medical professionals for quite some time that it can do CT (including the "noise-free simulation" slide shown on the TV screen near the end of the RSNA 2020 presentation, 24:04).

That simulation was supposedly done with an imaginary device with 11 sources and detectors that don't exist.

But Nanox admits in its Prospectus that it intends to do only tomosynthesis - no usable axial slices can be produced.  CT or CAT is a short-cut for Computed Axial Tomography.  See also below.

Does the proposed Nanox.Arc 2.0 have 5 or 6 x-ray sources?

The information about the 5 x-ray sources comes from a video showing the making of Nanox.Arc 2.0.  If one pays close attention at 0:19-0:20, one can see the holes of the 5 sources.  I tweeted about it and so did Nanox promoter, but he did not count the holes.  

counted by me

not counted by promoter

The CEO was lying throughout the RSNA 2020 presentation that the device had 6 x-ray sources.  If the sources were so precious and novel, he would have gotten a least the number correct, as this was the first public demo of the source.

Here is how Nanox advertised its presentation on its exhibitor page at RSNA 2020:

Nano-X Imaging Ltd Nanox is a developer of MEMs based electrons field emitter cold-cathode, enabling the manufacturing of digitally controlled, low-cost x-ray tubes. Nanox's technology is under third party review, pending 510k clearance. Please join the Virtual Meeting Room button below at 10:30 am CST on Thursday, December 3 for a Featured Demonstration as Nanox unveils a proprietary digital X-ray source based on a silicon MEMs electrons field-emission technology. The presentation debuts a novel X-ray tube that emits digitally controlled X-ray pulses and can be used across multiple medical imaging use cases. https://www.nanox.vision 

So, what is the main proposed modality of Nanox.Arc 2.0?

Page 1 of the Prospectus explains that the main use of the Nanox.Arc that Nanox supposedly plans to commercialize is tomosynthesis:

Subject to receiving regulatory clearance, the first version of the Nanox.ARC that we expect to introduce to the market will be a three-dimensional (“3D”) tomosynthesis imaging system. Tomosynthesis is an imaging technique widely used for early detection, that is designed to produce a high-resolution, 3D X-ray image reconstruction of the scanned human body part for review by a professional diagnostics expert

Slide 8 from the March 17, 2021 Oppenheimer presentation states: 

The Nanox.ARC 3D computerized tomosynthesis:  New breed of medical imaging.  

Also, if one looks carefully during the RSNA 2020 presentation video (for example, at 12:55), what Nanox appears to be doing for any "scan" is collecting 45 images (5 sources x 9 tilted positions) and creating synthetic slices from them in a plane parallel to the flat detector placed in the "box" below the arc.

Can the proposed Nanox.Arc, either single-source or 2.0, do fluoro?

According to Nanox, Nanox.Arc can do fluoroscopy (even though it is not its main use case), but Nanox can also license its proposed x-ray source to traditional device manufacturers to incorporate in their own fluoroscopy systems (the white paper addresses that second case).  Today's fluoroscopy systems are very simple - a single source (pulsed, for two reasons - to prevent source overheating, and to reduce radiation exposure) and a fast detector (10+ fps) - clearly a single-source Nanox.Arc can do it (for say, $200,000/unit) ,assuming a powerful enough hot-cathode dental source with a stationary anode (but the best price quote for a new system I have gotten is $28,500/unit FOB Shanghai, and it is not cleared yet in the USA, so it cannot be used as a predicate).  

Slide 20 of the January 2020 presentation at JP Morgan shows the multi-source Nanox.Arc device doing "3D fluoroscopy" (I guess you need a Hololens or Oculus headset for it) using 3 of the 5 sources. 

Yes, fluoroscopy has its own product code(s) for 510K clearance purposes (for example, JAA), but a system can have more than one product code for clearance purposes.

Update:  Here is the completely-misleading slide from the January 2021 JP Morgan presentation that shows that the proposed Nanox.Arc 2.0 can replace the Chinese fluoroscopy system, among others.  See also my previous post, focusing on cost.

The chip that proves that Nanox is a fraud

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

 

Let's magnify:

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

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

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

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

A reason

There are many reasons why I suspect that Nanox did not submit anything to anyone for FDA clearance, or if it did, it did so fraudulently. 

Here is one.

It is February 7, 2020. The month of January had been very exciting at Nanox because the team finally submitted the super-secret single-source device for FDA clearance, after getting it to work and completing extensive testing with it at Hadassah.  No more need for fake videos showing fake tests of fake devices.  Right? Everybody is excited and still celebrating - even the lawyers and the assistants know what Nanox has achieved - they are getting rich! So what does Nanox do? It files a draft registration statement with the SEC and states on page 1: 

As a first step, we plan to submit a 510(k) application for a single-source version of the Nanox.Arc to the U.S. Food and Drug Administration (the “FDA”) in January 2020.

Plan to submit?  But it is February 7 already!  It should read "we submitted!"   How come whoever wrote the filing forgot about the submission?  On page 1, not buried on page 146 or something...

And what else do we learn in that draft registration statement on page 9?

We have not produced a working prototype of the Nanox.Arc

Wait, what?  How can you do testing, if you don't even have a working prototype?   Where did all the numbers and images in the submission come from?  How did Nanox write these sections in the submission without a working device:  Specifications , Substantial Equivalence Comparison, and Performance? 

Note that regulations require that all

510(k) submitters must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. 

So, did Nanox file a false draft registration statement with the SEC, or did Nanox made false statements to the FDA, or maybe both?

Note:  The fake video of the fake device titled "Nanox ARC  -  Raw chest scan demonstration," that was later "updated," was initially encoded on February 25, 2020.  Here is a snapshot.

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device, not the one shown here).  So, the draft registration filing was erroneous or the clearance submission was fraudulent.  More hints will be revealed in the summary that will be published around May 1st.  

Nanox CEO caught lying again

According to Nanox CEO, 

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

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

Source:  Yole via EETImes.eu