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The draft registration statement filed by Nanox in early February states that the company is planning to file for clearance, meaning it did not file in January. Same draft registration statement says the company has "not produced a working prototype of the Nanox.Arc" (a later draft registration statement says it was produced in February).
A single-source unit may have been available for a century, but the FDA and the EU say it must pass certain safety and effectiveness thingies, including HVL and S-Values and non-fake images. And the company should not lie to the FDA or the Third Party or the investors about what x-ray source is used in the unit. Yes, the FDA has approved devices that also use a dental tube (including a 2 mA one for limited intended use such as extremities, which is worse than Nanox' 11 mA from the hand drawing), but at least that dental tube is not crappy.
Nanox tried to fool the FDA, or tried to fool the investors, or both.
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