Hanlon's razor

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?

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.