Approval and Screening

I had somehow missed a piece written by three doctors on tomosynthesis.  It is intentionally misleading, but rather silly, so probably no need to go into all the details.   Its second sentence starts like this:

Since receiving FDA clearance in 2011 for screening mammography, digital tomosynthesis (DTS) technology has become virtually synonymous with 3D breast exams...

But it was FDA approval, not clearance.  Moreover,  the approval clearly states: 

THE SCREENING EXAMINATION WILL CONSIST OF A 2D IMAGE SET OR A 2D AND 3D IMAGE SET.

So, the DTS, that is 3D, by itself is not sufficient for screening, according to the approval.

And then it gets worse.

Why is all this important?  Nanox has been intentionally confusing its investors by promising FDA approval, when all it ever did was seek clearance (by submitting a fraudulent application to a fraudulent third party).  And, of course, tomosynthesis (other than breast) is a dead imaging modality that the ACR Appropriateness Criteria® don't even consider as ever being useful.

The authors, all on Nanox payroll, are Dr. Yuz, fined and put on probation for fraudulent medical practice in his youth, Dr. Dawson, who was fired but then pretended to be a whistleblower, and Dr. Katske, the man "credited" for the whimsical production known as RSNA 2020 Nanox live demo.

Update:  Jonathan @Yahoo questions whether Radiology Today has a disclosure policy that would force the 2nd two authors to disclose a financial interest in Nanox (all the three authors were affiliated with Nanox at the time of publication, of course).  He also loves the line “CT is burdensome to radiologists”.  He finally guesses that it is burdensome "in the same way developing a real product and generating actual revenue is burdensome to" Nanox.