Shares of medical imaging technology company Nano-X Imaging Ltd NNOX are trading higher Monday after the company said it received 510(k) clearance from the FDA to market the Nanox.ARC as a stationary X-ray system.
What To Know: The FDA cleared Nano-X to market Nanox.ARC and its cloud-based infrastructure Nanox.CLOUD. The x-ray system is intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography.
Nanox.ARC's digital 3D tomosynthesis system uses novel, cold cathode X-ray tubes. It was cleared for use in professional healthcare or radiological facilities.
"Our vision is that Nanox's innovative technology and approach not only have the potential to increase access to medical imaging, but also to shift healthcare from reactive to proactive—enabling early detection and prevention of diseases," said Erez Meltzer, CEO of Nanox.
The FDA clearance creates a path for additional approvals in other countries. The company said it will continue to work with the FDA on additional regulatory clearances.
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NNOX Price Action: Nano-X shares were up 42.2% at $8.70 at the time of writing, according to Benzinga Pro.
Photo: Daniel Alvarez from Pixabay.
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