Axonics® Submits PMA Supplement to U.S. Food & Drug Administration to Expand Full-Body MRI Labeling for 3T Scans
Axonics, Inc. (AXNX)
Last axonics, inc. earnings: 3/4 04:01 pm
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Source: Business Wire
IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of a premarket approval (“PMA”) supplement to the U.S. Food & Drug Administration (“FDA”) for the purpose of gaining full-body magnetic resonance imaging (“MRI”) conditional labeling for 3.0T MRI scans.In September 2019, the FDA approved the Axonics r-SNM® System with full-body conditional labeling for 1.5T MR scanners. Axonics has since performed all the required tests to support a PMA supplement for full-body conditional labeling on 3.0T MR scanners for the implantable components of its r-SNM System. The FDA review timeline for labeling expansion PMA supplements is 180 days.Raymond W. Cohen, Axonics CEO commented, “The Axonics r-SNM System is already approved for 1.5T and 3.0T full-body
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