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You want to understand $NNOX news for today you have to understand NNOX. I’m nice so I help. They make novel digital xray source. The call it Nanox Source. It creates 2D xray images. This is what NNOX submitted to FDA for 510k approval. They call it “single source.”
NNOX wants to expand the applications of Nanox Source beyond 2D xray. To do that they created Nanox.ARC. Know why they chose name ARC? Because it looks like a damn ARC. It creates 3D images. Know how it creates 3D images? By using MULTIPLE Nanox Source units (multi-source).
Now have a look at the FDA deficiency statement. They refer to the Nanox Source (single source, 2D xray) as “predicate device” and they ask about Nanox.ARC (multi source, 3d imaging). NNOX did not apply for multi source yet because they need Nanox Source (single source) approval.
So FDA asks how Nanox Source (predicate device) is comparable to Nanox.ARC That’s simple: multiple predicate devices are arranged along an ARC to capture multiple images. But NNOX has not applied for Nanox.ARC approval yet. In fact, that’s what the rest of form 6-k discusses.
Here, "In addition, the Company will continue to optimize and develop features of the Nanox.ARC, and plans to submit an additional 510(k) premarket notification to the FDA with respect to the multiple-source Nanox.ARC and the http://Nanox.CLOUD during 2021."
Most generous view would be that NNOX did not sufficiently document details of Nanox.ARC because they planned to do so in seperate 510k application. But FDA wants more details to better understand intent behind submitting Nanox Source as stand alone when business model is ARC.
I think NNOX proud of their novel technology and wants to simplify process of approving the core technology. FDA wants to better understand how multiple Nanox Source working in Nanox.ARC differs. Best not to assume things so FDA doing due diligence and NNOX complying.
Some links:
Form 6-K https://seekingalpha.com/filing/5334494
Nanox.ARC page:
https://www.nanox.vision/our-technology
John Nosta holding Nanox Source: https://twitter.com/JohnNosta/status/1344027517569675264?s=20
Form 6-K https://seekingalpha.com/filing/5334494
Nanox.ARC page:
https://www.nanox.vision/our-technology
John Nosta holding Nanox Source: https://twitter.com/JohnNosta/status/1344027517569675264?s=20
