Remember that Bloomberg piece that Nanox tweeted in early March?
How to tell? Easy. You look for the fake dust particles that the video editor introduces subconsciously in the video walk-down of the fab and then posts that clip in the lowest-possible resolution on Youtube.
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| Nanox temp Korean FAB featuring Nikon NSR-S204B scanner introduced 23 years ago. |
Today's Nanox AI event showed a sample image from "nanox.Arc demo unit" that was not submitted for regulatory approval.
Can someone explain what I may be seeing here - aren't there too many bones? Was this early detection of an alien lifeform living inside a phantom human hand?
Update November 5, 2021: The recording of Nanox AI event posted on Youtube has been made private and cannot be viewed anymore. I wonder why. Time to notify the FDA about the alien discovery by a device about to be cleared?
Update November 9, 2021: Recording is viewable again, under new URL.
Update November 14, 2021: I was asked on Youtube how I can be sure that the June submission for FDA clearance was fraudulent. Dr. Orit, the Chief Medical Officer, admitted during the webcast that 1) the Nanox.ARC device is currently under development (49m:44s), and the "images" [including the disastrous tomosynthesis slab of the "alien lifeform" hand] are currently not usable for diagnostic purposes - "it is still being developed" (52m:07s). Therefore, the device submitted for clearance in June was not ready to be marketed or tested, which is fraud.
Nanox states in each of its recent press releases that
Nanox ... is an Israeli corporation
Surprisingly, its website lists only English, Korean, Chinese, and Japanese as available languages. The country's official language, Hebrew, is somehow missing.
This is not an accidental omission. The website of the CEO's related scam, DHI 2048, which describes itself as
UAE-based organization
is only in English, and has no option for Arabic, the official language of UAE.
Why is that?
During the August 16 Business Update, which was supposed to show the latest and greatest by Nanox, Dr. Kim, a convicted felon, said:
... we are now manufacturing MEMS chips from our own facility [in Korea]
Turns out, they were not manufacturing MEMS chips in Korea, at least not in a finished form.
According to his latest interview, things are done half in Korea and half in Japan (just as the CEO had described during an earlier results call on August 11).
Here is the translation:
It appears that Nanox CEO really wants to admit that the 510(k) submission to the FDA in June was fraudulent. In an interview with Korean Economic TV (wowTV), conducted in early October, he supposedly said the following when asked about the commercialization plans for Nanox.Arc in 2022:
We expect 2022 to be the year of Nanox equipment deployment. It won't be on a global scale, but we still expect deployments to be completed in some countries. We have already demonstrated the Nanox.ARC several times before the last RSNA [meeting in December 2020]. Therefore, interest in Nanox is increasing and it is getting very close to mass production. But we're at the doorstep of getting medical regulatory approvals. To this end, Nanox plans to do a final check to see if the system is working properly through a process we call 'dry run'. As such, we are looking forward to seeing the Nanox Arc in action in the field within 2022. [rough translation from Korean with google translate]
Hmm, if the final check of the Nanox.Arc has not even started, then the submission for FDA clearance in June was clearly incomplete and fraudulent. If Nanox does not know yet whether the device is working properly, than, obviously, it cannot claim that the device is substantially equivalent to any device on the market.
The problem is that neither wowTV nor Nanox released the full interview, so right now there is no way to check whether the CEO really said all that. The version of the interview released on Youtube is substantially edited, with large portions, including this particular statement, cut.
Some of the main takeaways from the shortened version are:
Takeaway 1: The upcoming world-class CEO was quite incoherent (not a surprise, since has was fired from his position as a Chair of Hadassah Medical in December last year). Here is what he said.
As were are right now in the middle of the process of planning the [?] operating for next year, and following our visit next week in Korea, we are already deep into the process of planning for next year. Following these 3 acquisitions which the closing will be in the next few weeks - we expect and we thought that the closing of Zebra will be in October - we don't see any challenges to do so - next will be USARAD and MDW, and once we complete the post-merger integration, that's actually what we do right now, we are planning to go for the next step. And the next step is to finalize the products, do the final submission to the FDA, make all the preparations for the mass production. and start to get the regulation approvals in various countries, as well as the selling and implementing and bring to the deployment of the agreements that were already signed and new agreements that will be signed in the very near future. At the same time we are going to explore and expand the revenues that we already have in Zebra and MDW and USARAD - actually scale it up to become more and more, and implement the agreements that were signed with Zebra on the AI and the population health - and what we call the Robodiologist going forward - so basically the whole theme will be next year execution, implementation, deployment, and scaling up.
Takeaway 2: The current CEO falsely claims, again, that the FDA clearance of Nanox.Cart is a key validation of Nanox digital x-ray source and that the FDA said that "this technology actually meets a predicate device." The truth is that the clearance was a farce, as evidenced by the contradictory 510(k) summary regarding the source (such as its target angle), there is nothing digital about the supposed x-ray source (tube) in the Nanox.Cart, and that the FDA does not clear technology but only a specific device.
Takeaway 3: The current CEO reversed two statements in the June press release and now claims the "first-version" device submitted for FDA clearance in June will be the one that will be made and deployed based on the signed agreements with customers. The press release had stated,
The first version of the multi-source Nanox.ARC will be followed by future Nanox.ARC versions,
thereby implying that the device submitted in June will not be commercialized, just as the Nanox.Cart.
He also reversed the statement in the press release about the device's intended use:
Nanox.ARC is a 3-D tomosynthesis imaging system that produces scans of a human body part.
In the interview, it is back to full-body scanners (not a body part).
Takeaway 4: The usual lies by the current CEO that most of the population of the world do not have effective access to medical imaging, that Wilhelm Roentgen invented x-rays 126 years ago with a hot cathode, that micro-electromechanical is nano-scale or that the proposed Nanox chip has anything to do with either, and that chip-based tubes are digital, colder, lower-voltage, and less expensive than regular dental tubes.
Takeaway 5: The current CEO can joke:
I said before, X-ray was invented 126 years ago, Nanox - we are inventing now. So we should look forward another 126 years of Nanox different product - coming from Nanox technology, because we believe that this is the technology of the future for medical imaging.
It is funny, because it is an inside joke, of course. X-ray was not invented, and Nanox is not inventing anything now. The real Nanox products will come in 126 years - you just have to look forward to them - it is a technology of the future, not of the present. In other words, the FDA, for the first time ever, has approved a technology that will not exist for another 126 years.
If Nanox had even one bit of useful technology, why would the CEO be compelled to lie every time about it when he speaks publicly?
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| Source: wowTV |
Following is an excerpt from the CEO interview at the unveiling ceremony of the unfinished Nanox Korean FAB that is supposed to produce fake chips and come online in the middle of the biggest chip glut next year.
126 years ago Wilhelm Roentgen invented the Edison light of X-ray, called X-ray. It is analog. It is based on heat. Nanox invented the LED of x-ray, which is cold and digital, and much reduced cost. X-ray was based on filament, but with Nanox, it is based on semiconductor.
We are very close to SK Hynix, which is one of the largest MEMS semiconductor manufacturers, and it is very similar to what we do here.
Lie Number 1: Wilhelm Roentgen did not invent x-rays - he discovered them using equipment that already existed - the cold-cathode tube. He said so in the first paragraph of his paper:
... a Hittorf's vacuum tube, or through a well-exhausted Crookes' or Lenard's tube." (translation, original).
Nanox CEO is, of course, aware of this fact, as the Roentgen paper is cited in the first paragraph of Nanox own white paper on cold cathodes.
Those are all cold-cathode tubes and they do not have filaments. The filament-based or "hot-cathode" x-ray tube was not invented until 1913, according to the first page of Nanox white paper.
Lie Number 2: X-ray generation for medical imaging is not and was never based on heat. Heat is a side effect of the inefficient way of x-ray generation in the x-ray tube. In any x-ray tube, electrons driven by very high voltage smash into an anode target, and release less than 1% of their energy as useful x-rays, while the rest is wasted as heat. The process is exactly the same for both the cold and hot cathodes.
Lie Number 3: Nanox has not invented anything. Nanox proposed x-ray source is supposed to be a cheap dental x-ray tube - it has nothing to do with an LED. X-rays, unlike visible light or even UV light, cannot be generated by LEDs, as the semiconductor bandgaps are not wide enough. The proposed Nanox tube is just as analog and digital as the regular dental x-ray tubes, but would be more expensive if real (because any chip, obviously, would be more expensive than the filament - a short piece of wire) and would have worse performance. Of course, a fake Nanox tube must cost less than a regular dental x-ray tube (which can be bought on eBay for $80 or so, nowhere near the $150,000, or $50,000 lately, claimed by the CEO elsewhere).
Lie Number 4: Nanox proposed (and fake) x-ray source is not based on semiconductors. Nanox annual report states (page 59):
Our X-ray source is a MEMs-based semiconductor cathode that achieves electron emission by a non-thermionic low-voltage trigger to approximately 100 million nano-scale molybdenum cones that act as multiple electron “guns,” instead of a single heated filament.
Molybdenum, however, is not a semiconductor (it is as conductive as the filament's tungsten) Oh, and Nanox "low-voltage trigger" is supposed to be 50V (per white paper), while traditional filament uses less than 5V.
Lie Number 5: SK Hynix is not one of the largest MEMS semiconductor manufacturers. Those would be Bosch, Broadcom, Qorvo, STMicroelectronics, Texas Instruments, Goermicro, HP, Knowles, TDK and Infineon. SK Hynix makes real memory chips, while Nanox has never designed or made a single working chip that can serve as a cold cathode of a commercially-ready x-ray source, contrary to its investment presentations. The proposed Nanox chip is not MEMS anyway, as there is nothing mechanical or moving/vibrating/resonating/etc. about it - it is supposed to be just a bunch of pins in round "holes."
Update: SK Hynix is nowhere to be found in this chart by Yole, even though SK Hynix insists that it has some MEMS business (microphone and pressure sensors planned on its foundry side).
Nanox August Business Update webcast, supposed to show "the latest and greatest of Nanox" (per CEO), demonstrated that Nanox has no working Nanox chip, x-ray source, or Arc, contrary to the intentionally misleading claims read by the webcast participants, and confirmed that Nanox had submitted a non-working medical device for FDA clearance in June.
Here is a particularly hilarious snapshot from the webcast. It is supposed to show the next-generation high-power x-ray tube successfully developed by the Nanox Korea team led by a convicted felon, Dr. Kim.
Did you know years ago, after an xray, you had to under go treatment for xray burn.? The goal in xray is less radiation, precise dosage / area control. Ask which is more controllable, digital or analogue. Start to see the future, instead of a few months ahead. Someone can..., I asked the surgeon if all those x-rays may have been a cause. He said that any x-ray taken before 1990 could be classed as a "dirty" x-ray, due to incorrect dosage or leakage from the machine, and failure to shield those parts of the body not being x-rayed.
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| Source: National Museum of Health and Medicine, circa 1915 |
Not possible, says the United States Code of Federal Regulations. Coal mine operators are required to provide radiographic examinations to each coal miner, and, for some reasons, the law insists on certain minimum specs of the equipment. Nanox.Arc cannot meet them.
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| Original credit: Jean Beaufort |
Here are some of the specs for a digital radiograph (42 CFR 37.42) that Nanox.Arc fails:
Every digital chest radiograph taken as required under this section must be a single posteroanterior [PA] projection
Nanox.Arc cannot take PA projections (it can only do supine AP).
Radiographs must be made with units having generators which have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage must be at least the minimum as recommended by the manufacturer for chest radiography.
Nanox tube is rated just 2mA at 40 kVp, per 510K Summary for Nanox.Cart. Nanox partner CEI has been supposedly trying hard for months to make 1mA at 100 kVp, but has failed so far.
The distance from source or focal spot to detector must be at least 70 inches (or 180 centimeters if measured in centimeters);
The Arc is too tight and the distance is less than 40 inches.
The geometry of the radiographic system must ensure that the central axis (ray) of the primary beam is perpendicular to the plane of the CR imaging plate, or DR detector and is correctly aligned to the grid;
The requirement above is met by only one of the 5 tubes in the Nanox.Arc, in only one, the no-tilt, position of the Arc.
Now, if the Arc cannot even do a simple radiograph worthy of a coal miner, why does Nanox still tell investors that the Arc can be used for chest diagnostics?
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| Slide from Cantor investor presentation (September 29) |
Moreover, does the FDA clearance submission of the Nanox.Arc list chest diagnostics as an indication/intended use? That would be a bit fraudulent, no?
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| Predecessor logo (2015-2019) |
NanoX Technology
After more than 20 years of research and development [placing the beginning before 1996], with over $1B invested, our team of engineers has created a technology that will form the core of the next generation of vacuum electronics. Nanox field-effect electron sources will allow engineers in diverse industries to overcome decades-old impediments to innovation. Nanox technology will open the door to quantum leaps in medical imaging, security sciences, and telecommunications.
While the fake $1B number remained, six years of research and development disappeared. For example, Nanox current tech page claims over 19 years [placing the beginning before 2002]. Years don't disappear, unless the story and the technology is fake.
Also interesting is the list of frequently-asked questions about Nanox in February of 2016.
Q: How much do Nanox emitters cost?
A: Nanox will enter the market as a technology license provider, not as a component supplier. We are committed to working with our co-development partners to craft business relationships that allow both sides to capture maximum value from their investments.
Because the technology was and still is a scam, no one has licensed it. Not even Fuji, which is fraudulently listed as an OEM above.
Q: How large are Nanox cathodes?
A: Nanox cathodes are created from standard silicon wafers using well-known MEMS fabrication techniques, and can be created in any shape, size, or configuration.
Nanox now claims the (fake) cathodes are about 1cm2.
Q: What current density has been achieved?
A: Over the past year, Nanox has made numerous improvements that have resulted in large jumps in current density. We are now routinely testing emitters rated at 2.5A/cm2
If the emitters were real and had current density of 2.5A/cm2, the Nanox tube would have been a very powerful one - 100,000W (40,000V x 2.5 A/cm2 x 1 cm2), capable of doing soft-tissue CT. Instead, the Nanox tube is just 80W, which is worse than the cheapest used dental tube you can buy on eBay. So, Nanox predecessor "exaggerated" by more than 3 orders of magnitude (or, a factor over 1,000x), even if the technology were not completely fake (which it is).
Which brings us back to the most frequently asked question about Nanox today:
Q: When is the FDA approval coming?
And the answer is:
A: Never, as Nanox has not submitted for FDA approval.
Just looking at history is often enough to reveal a fraud. Here is what Nanox predecessor (current CEO was CSO then) claimed about the prospects of its "technology" more than five years ago. Just as fake as it is today.
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| Question posed by Nanox predecessor in November 2015 |
Mammography
Nanox technology offers a way forward.
Never did.
Hot cathodes are limited in the amount of power they can put out at the low photon energy levels required for breast imaging, resulting in long exposure times (which are uncomfortable for the patient) and increased motion artifact (which degrades image quality).
Completely false. All breast x-ray imaging still uses hot cathodes, which work great.
Nanox cold cathodes are not subject to the same physical limitation; high power can be put out at low photon energy, resulting in very short exposure times.
Completely false. According to the 510(k) Summary, the Nanox tube is limited to 80W of power, while a regular mammography tube is at least 6x as powerful ( 500W to 10000W), cutting exposure time by at least 6x.
Nanox cold cathode-based 2D mammography will give our OEM partner a clear advantage over their competitors.
Nope. Nanox never got any OEM partner, contrary to its fraudulent investor presentation slides.
[2D mammography] is anticipated to be one of the first applications of our technology, because it does not require significant changes to the design of existing machines.
The same argument was made in the Nanox mammography white paper, the link to which has been removed from Nanox website since January 2021. It may yet become true, as there are have been no applications whatsoever of Nanox "technology" yet.
3D mammography (aka breast tomosynthesis) has proven to be superior to standard 2D in breast cancer detection.
Nope. Not proven yet.
It is widely accepted that 3D will become the new standard for screening mammography within the next 5 years.
Nope. More than five years passed, and it did not happen.
The way in which tomosynthesis is currently performed leaves much to be desired, and Nanox technology has the potential to improve upon every pain point of this modality. Nanox technology will keep our OEM partner at the forefront of breast imaging.
There is no potential for a fake technology, and, again, Nanox has no OEM partner.
CT
Current state-of-the-art CT machines rely on expensive and cumbersome electronics to meet image quality goals. Nanox technology allows radical simplification of electron beam focusing, resulting in improved sampling and image quality. We anticipate that floating focal spot cathodes for use in standard contemporary moving-gantry CT machines will be one of the first applications of our technology, because our cathodes will simply serve as an upgrade for the hot cathode in existing machines.
Nope. No floating focal spot cathodes are on the horizon.
Contemporary CT machines are operating at the limits of engineering. Weighing more than 1.5 tons, and spinning at more than four rotations per second, acceleration forces are five times greater than those of a fighter jet. They require power supplies that take up an entire room, and they weigh so much that the floors under them require special reinforcement. And because CT machines are large, heavy, and immobile, even critically ill patients must be brought to the CT scanner, resulting in significant danger.
None of this is true. For example, cheap portable cone-beam CTs are used in dentistry. Some Brain CTs are quite portable and small, too.
Nanox cold cathode technology enables the “holy grail” of CT imaging: CT, with no moving parts. While this will require a large investment in new overall system configuration and detector technology, the potential cost benefits to the manufacturer are enormous. There are several potential applications, which define separate verticals.
Radiation Therapy
External beam radiation therapy is one of the mainstays of modern cancer therapy. Linear accelerators (Linacs) create the treatment beam by accelerating electrons to near the speed of light. Nanox field effect cathode technology has the potential to improve the precision and efficiency of Linear Accelerators, which may translate to better outcomes for patients.
Nope. No potential.
Live Tomosynthesis
Tomosynthesis machines based on hot cathodes are slow and low-powered.
False. All tomosynthesis machines based on hot cathodes are faster and higher-powered than the proposed Nanox.Arc (which is not even functional yet). For example, the Arc "version" (never to be seen again) supposedly demoed at RSNA 2020 took about 45 seconds for a low-quality artifact-filled scan of a phantom hand, a record slow!
But combined with Nanox cold cathode technology, tomosynthesis can be transformed into something much more valuable: for the first time ever, low-dose, real-time, 3D imaging becomes possible. Live tomosynthesis has several different potential applications, which define separate verticals.
Nope. All this is already possible and widely available.
Interventional cardiology: Precise real-time imaging is needed to guide the accurate placement of devices such as angioplasty balloons, stents, and artificial valves into the heart. Existing angiography systems offer only live 2D imaging, or retrospective 3D imaging. Live cardiac tomosynthesis would offer clearly superior live 3D imaging.
Nope. All this has been available for years in C-arm cone-beam CT systems.
Radiotherapy guidance: The field of radiation oncology has struggled for decades to accurately target tumors that move during treatment, such as those in the lung. Combinations of prior imaging, triangulation based on surgically implanted devices, and guesswork have been developed, with limited success. A distributed source system using Nanox cold cathodes would enable real-time 3D tracking of tumors while they are being irradiated, allowing increased dose to the tumor while minimizing toxicity to surrounding tissue. This could allow the treatment of previously untreatable tumors, and improve outcomes of current protocols.
Again, nope.
Surgical guidance: Surgical guidance systems are used to help surgeons localize anatomical targets and avoid injury to adjacent normal tissue. Current systems use images taken at one point in the past, and then deform them based on live information from specialized external markers and dedicated surgical tools. These techniques are limited by the fact that they cannot account for large changes made during the surgery itself, such as the introduction of implants. The use of real-time 3D imaging to update preoperative CT imaging would ensure that the information surgeons are using is always accurate.
Again, nope. May have been true 50 years ago.
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| Answer given by Nanox predecessor in November 2015 |
A recent Fool.com discussion, by two characters who know little about the topic, concluded that there is a lot to like about Nanox, except for some minor "regulatory" risk:
The question is, does [Nanox tech] work? Yes. Is it a fraud? No. That's been answered.
That conclusion is obviously wrong - Nanox "technology" does not work, and the extent of the fraud is not yet publicly known.
Hanlon's razor usually applies to situations like this, but at what point does the razor turn dead blunt?
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| Source (cropped) |
Let's clear (pun intended) some of the "misconceptions" advanced during the discussion.
Nanox has not proven that its technology works. In fact, Nanox has proven the exact opposite. Its proposed Nanox.source "chip" is fake (and so, the FDA clearance of any device that claims to use that chip must be invalidated due to fraudulent submission). Its proposed Nanox.Arc device is not functional, as evidenced by the August Business Update (and so, any prior FDA submission of that proposed device must have been fraudulent). The fact that a company has obtained FDA clearance in no way proves lack of fraud, as evidenced by the FDA clearance received by the fraud Theranos. It is safe to assume that existing players in the medical imaging market do not fear "a disruption" by Nanox, although they might be a bit envious of Nanox story-telling ability and valuation.
The FDA does not have a special type of clearance for "novel" devices. "Clearance" means the FDA has determined a device is substantially equivalent to an existing medical device, based on a submission by the device manufacturer (even if that submission were erroneous or fraudulent). Novel devices can obtain De Novo marketing authorization or FDA approval. Truly breakthrough devices have their own regulatory path. But the proposed Nanox.Arc, even if it were not fake, would be a simple low-quality tomosynthesis device that cannot be used for mammography, just like many other similar tomosynthesis devices (or simple upgrades to devices) offered by virtually all existing players over the decades that could never get even 1% market share. Such a device simply cannot generate diagnostic images comparable to images generated by CT (specifically, axial slices), and even less by MRI (which doesn't even use x-rays). Even if it could be made for $10,000 (and function as proposed, which it cannot), it simply cannot compare with a $1,000,000 device. Neither can any of the $500 or so hand-held x-ray devices that can be bought online and that use higher-performing x-ray tubes.
Nanox proposed business plan is not razor-and-blades, but a modified pay-per-use model, which has consistently failed in the real medical device market in the past, but would be great for money laundering. According to Nanox disclosures, the proposed device will typically be delivered "for free," in exchange for a minimum guaranteed payment over 3 years, with a scan typically bringing $14 of the proposed $40 cost to the patient (of which $10 will be kept by Nanox - that's 25% not 40%). Not really cheap, given that an x-ray medical imaging is easily accessible all over the world and a chest scan (the most popular x-ray scan) can be had as low as $3 in some countries (for example, Nigeria).
Going back to the technology, the machines don't have to be heated up to generate x-rays - just as the Christmas tree doesn't need to be heated up for its lights to operate. Yes, the filament in a x-ray tube gets a bit hot (lower temperature than that of the filament in a Christmas tree light), but 99% of the heat actually gets generated on the tube's target, not the filament, for both real x-ray tubes and the proposed Nanox tube. It is the anode in the proposed Nanox tube (a low-quality, stationary-anode dental tube) that can quickly get to 3,400 degrees Celsius.
Neither Foxconn nor SK Telecom is going to manufacture any Nanox devices anytime soon, based on the latest Nanox disclosures. And, of course, Nanox is not using any Sony technology. Contrary to the fairy tale, Sony got access to the failed cold-cathode technology in 1998, when it saw the end of CRT TVs:
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.
But nothing came out of the tech. The cold-cathode tech was always a scam, as Sony must have realized quickly - and it was obvious to everyone when the Sony's source of the tech, Candescent, filed for Chapter 11 in 2004. So the "assets," that is liabilities, were carved out in 2005 to Field Emission Technologies, and that closed doors in 2009, with nothing to show for the "effort." By 2013, the "team" had pivoted to x-ray detectors, which again proved to be a complete failure. By late 2015, Nanox current CEO, then Chief Strategy Officer of Nanox predecessor, was trying to con
serious co-development partners to bring this exciting [cold-cathode emitter] technology to market.
With zero success, of course.
According to Nanox tech white paper (page 15),
Nanox’s chip and tube design can change the size, position, and shape of the tube focal spot.
But take a look at Figure 10 which is supposed to show the "Digitally flexible focal spot," whatever that might be. The charts in that "figure" are completely blurred and out of focus themselves. There is absolutely no telling what is shown on them, and that has to be intentional. Here is the first one of the seven "charts" in the figure.
Ironic, isn't it? A chart of a focal spot that is out of focus. Just another indication that the company is a complete fraud.
October is here - the month of the scary things. Nanox presents to you the "Clond." The clond is scary because it is hot. But not to worry - Nanox will save the day because it is cold - its proposed photon source extracts electrons using a field of nano-gates. Get it now? What is really scary is that the FDA has already cleared a device by this company (even though Nanox has insisted that it has no plans to commercialize it).
Anyway, Nanox has no functioning device yet, but has redesigned its logo and website, and republished its "tech" white papers. Which would be ok, except that no one at the company (no one who understands x-rays, that is) has bothered reading those papers, as they contain the same old obvious errors and stupidities, proving again and again that the company is a complete fraud.
Let's take a look at this diagram, for example, from the "Hot Cathodes, Cold Cathodes" witchcraft scroll:
The diagram is supposed to show us the difference between a hot-cathode and a cold-cathode x-ray tube. The cold-cathode tube has no cathode cup and no anode for high voltage. The missing cathode cup, which focuses the electrons, is not critical, but the missing anode's high voltage is. See, without high voltage, an x-ray tube cannot generate any x-rays. None. That's far worse than the "electron clond" vs electrons. Oh, and what happened to the rotating anode that was supposed to be needed for the "cooling" of the hot-cathode tube?
Here is a snapshot of the dental tube that Nanox claims CEI is currently trying to make work (but has failed so far, per Nanox Business Update webcast).
As you can see, the proposed revolutionary yet stationary-anode Nanox tube, contrary to the white paper, has a cathode cup and a copper high-voltage anode, and looks exactly like any other CHEAP DENTAL X-RAY TUBE that is available for $100 or so from various Chinese suppliers.
This snapshot from yesterdays' Cantor Fitzgerald Global Healthcare Conference is supposed to show how great Zebra Med is:
Answer: Revenues, even though Zebra Med boasts its own CPT code.
Note also that the slide below is a complete lie. Why? Because Zebra software can't tell whether a Nanox.Arc image is "normal" or not. Nanox.Arc is supposed to generate low-quality, short SID supine AP views, supposedly of chest or extremities, and artifact-filled tomosynthesis slices thereof with miniscule field of view. Zebra has no such views/data on which to train its algorithms and cannot obtain them for any money anytime soon. As of today, there is no evidence that any functioning Nanox.Arc device exists, so it will take years, thousand of working Nanox.Arc devices, and millions of dollars to generate the training data (millions of views) necessary to train Zebra's AI to perform even slightly better than a random coin toss.
That is something that both the current and future Nanox CEOs pretend to ignore.
On August 24, Benzinga reported:
Nano X Imaging Shares Spike Higher; Hearing Traders Circulate Co Has Signed 4-Year Distribution Agreement With Dubai-Based DHI
Signing a material agreement by Nanox is supposed to be followed by a 6-K or at least a press release. But those never came. Let's dig into it a bit further.
Apparently, Khaleej Times had reported about a "DHI 2048 launch event" in Dubai, supported by UAE's Department of Tourism & Commerce Marketing and attended by ambassadors from the UAE and Israel, as well as officials from health ministries and various authorities. At the event it was revealed that:
[Digital Health Innovation, or DHI, 2048,] the collaborative platform aims to install 2100 Nanox systems in public and private hospitals, train the workforce including nurses, and deploy artificial technology to create a robust healthcare ecosystem. The introduction of this technology is intended to promote the mission of providing a worldwide end-to-end medical imaging solution that enables people to have early medical detection and better health
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| Source: https://twitter.com/michaldivon/status/1430414620259504128/photo/2 |
Nanox is a company with a proven innovative technology in the medical imaging market and is committed to the cooperation between Korea and Israel. It symbolizes cooperation in research and development (R&D), assembly production and sales between Korea and Israel. Such corporate activities will serve as the basis for Israel's innovation and Korea's growth.
Deployment of Nanox systems, trainings and state-of-the-art AI technologies is just a start, and we aim to further accelerate the growth of health care sector with the support of our regional stakeholders.
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.
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| 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.
Nanox filed a 6-K today, claiming:
On August 12, 2021, NANO-X IMAGING LTD (the “Company”) received a request for additional information from the U.S. Food and Drug Administration (the “FDA”) concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC. The submission file is placed on hold pending a complete response to the FDA’s list of deficiencies. The Company’s response is due within 180 days from the date of the request for additional information.
The Company plans to respond by the due date which is 180 days from the date of the request for additional information. The Company expects to continue to optimize and develop further features of Nanox.ARC and is considering submitting an additional 510(k) application for the next version of multi-source Nanox.ARC during the fourth quarter of 2021, which will benefit from the FDA’s feedback on the first version of the multi-source Nanox.ARC.
This confirms that the Arc submitted for pre-market notification is not the one that Nanox plans to market, just like the Nanox.Cart.
But what is more important is the timing. Nanox did not mention any of this on its Business Update webcast on August 16, which showed improved images, some new tube prototypes, and some fancy user interface, but no technical data and no evidence that the Arc prototype is actually working.
This is what a MEMS chip looks like, according to Nanox' new website.
Junk @ Yahoo remarks that Bezalel Academy of Art and Design seems to train their students well, even the ones that can't graduate.
Previously, the chip looked like this (see circle in the middle):
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| Shay Azulay / Nanox via Engadget |
Here is the actual size, per Nanox tweet, with the dust specks, etc.
Here is the chip under "microscope" (as it says in Korean) from an RSNA 2020 video:
Update August 11, 2021: Edited a bit, for clarity.
Update August 16, 2021: The convicted felon Dr. Kim claimed at the Business Update recorded webcast today that these are "mems" chips manufactured at Nanox temporary "clean room" facility in Korea. Note the dust specs on virtually all the chips (unlike regular chips, these need to have an absolutely-clean surface if mounted in the proposed Nanox x-ray tube, or things go poof as soon as the high voltage is applied, in theory).
