NNOX - Nano-X Imaging gains on FDA submission for new digital X-ray technology
- Israel-based medical imaging firm Nano-X Imaging Ltd ( NASDAQ: NNOX ) added ~20% in the morning hours Wednesday after the company announced it submitted filings as part of a regulatory process to gain FDA’s 510(k) clearance for Nanox.ARC 3-D X-Ray system.
- In June 2021, the company announced the submission of a similar 510(k) premarket notification to the FDA for Nanox.ARC, also known as multi-source 3D digital tomosynthesis system.
- However, in August, NNOX said that the agency requested additional information related to the submission after finding deficiencies.
- NNOX received the FDA clearance for its single-source Nanox Cart X-Ray System in April 2021.
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Nano-X Imaging gains on FDA submission for new digital X-ray technology