Dry run

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.