By Chris Wack
Nano-X Imaging shares were 10% higher, at $4.93, after the company said it has received 510(k) clearance from the Food and Drug Administration for the Nanox.ARC X, its new multi-source digital tomosynthesis system.
The medical technology company said the FDA 510(k) clearance was received in less than 30 days from the date of submission.
The 510(k) clearance covers the production of tomographic images for general use, including the human musculoskeletal system and pulmonary, intra-abdominal and paranasal sinus indications, adjunctive to conventional radiography on adult patients.
Nano-X said the Nanox.ARC X is designed to be installed in any standard X-ray shielded room with minimal infrastructure requirements. The system operates on standard power and features a cable-free design for enhanced user and patient safety, ease of cleaning and maintenance.
Nanox will offer the Nanox.ARC X system later this year.
The stock hit its 52-week low of $3.75 on April 7, and is down 47% in the past 12 months.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 17, 2025 10:47 ET (14:47 GMT)
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