Nanox wins FDA approval for cloud-based X-ray system

Israeli medical imaging company Nanox-X Imaging (Nasdaq: NNOX), which has developed inexpensive, lightweight X-ray scanners, has announced that it has received marketing clearance from the US Food and Drug Administration (FDA) for the Nanox.ARC Cloud device and its cloud-based infrastructure.

Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography on adult patients. Representing a major advancement in X-ray technology, Nanox.ARC is a multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes, which the company plans to offer using an innovative pay-per-scan business model.

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Nanox held its Nasdaq IPO in August 2020, when it raised $165.2 million at a company valuation of $800 million. At one time the company’s market cap climbed to $3.5 billion before falling back to a market cap of less than $350 million. Yesterday the company’s share price jumped 68.4% to $10.29, giving a market cap of $567 million.

Nanox says its product is suitable for the US as well as the developing world where it signed distribution deals even before its IPO.

Nanox CEO Erez Meltzer said, “Today’s milestone is a significant achievement as part of our commitment to make state-of-the-art medical imaging technology available for use in a wide array of professional healthcare facilities and other medical practices. 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.”

Published by Globes, Israel business news – en.globes.co.il – on May 2, 2023.

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