Nanox announces FDA clearance of something

According to the press release, Nanox

single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the US Food and Drug Administration (the “FDA”).

Quite interesting, since the FDA, by law, cannot clear a technology, only a device.  It is also interesting that the mythical single-source device is nowhere to be seen on/in Nanox website, SEC filings, investor presentation, or any other marketing materials or white papers. .

an ugly device demoed at RSNA 2020

 

Nanox also confirms that it does not intend to deploy the device for which it received clearance:.

The Company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the Company’s commercial imaging system that it expects to deploy broadly across the globe.

That is really interesting, as 510(k) clearance is also known as pre-market notification, so it makes little sense to clear a device that it is not intended to be marketed.

But what is truly astonishing is that Nanox does not state in its press release that the device uses Nanox proposed "cold-cathode" x-ray source.  So does the device that just got cleared use a regular hot-cathode dental tube?

As of now, there is no public confirmation of the clearance by the FDA.  On Monday morning, the FDA should update its clearance database, and if the device got indeed cleared as Nanox claims, we will learn the product code, the name of the Third Party, and the date the Third Party recommended clearance, if there was any Third Party to begin with.  But we will have to wait for 30 days to read the Summary, where the predicate, intended use (extremities only?), and some tech characteristics will have to be made public...  And then Nanox will have some explaining to do - how do you enable early detection of cancer (also known as Nanox vision, or the oxymoronic "screening of symptomatic patients"), when all you are cleared to do is image broken wrists or feet?

Update April 4, 2021:  There is an argument floating around that an FDA clearance proves that the company is not a fraud.  The argument is flawed for at least three reasons:

1. Nanox claims that its Nanox.Arc device is novel.  A clearance, however, means that the company demonstrated that the device to be marketed is substantially equivalent to a legally marketed device.  Oops.  How can it be novel, if it is substantially equivalent to something already on the market?
2. A clearance is also known as pre-market notification.  But Nanox says that it has no plans to market/sell/ship/commercialize/deliver/deploy its single-source device.
3. Theranos, the fraud, also got clearance (in July 2015) for a device it did not intend to sell.  By January 2016, the federal government was after it.

Update April 5, 2021:  According to the FDA database, the device that was cleared is a cart - "Nanox Cart X-Ray System" - notice it is not named a (single-source) Nanox.Arc.  The product code is IZL (a mobile x-ray system).  There is no product code for a detector (MQB), so the device has no built-in detector, and so it cannot take images by itself (but should be able to use any $25,000+ cleared detector).  The clearance was recommended by a Third Party, Accelerated Device Approval Services, on December 28.  The summary should be released around May 1st.