Axonics submits PMA supplement to US Food & Drug administration to expand full-body MR labeling for 3T scans – DOTmed HealthCare Business News

Posted: April 7, 2020 at 4:07 pm

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 MRI scans in Europe. While only approximately 15% of MRI scanners operating in the U.S. are 3.0T, we believe it was a worthwhile investment to conduct the testing and analyses required for this filing and we are confident our PMA supplement will meet all criteria for FDA approval. This submission further demonstrates Axonics commitment to continuous innovation for the benefit of patients, clinicians and the healthcare system.

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Source: Axonics Modulation Technologies, Inc.

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Axonics submits PMA supplement to US Food & Drug administration to expand full-body MR labeling for 3T scans - DOTmed HealthCare Business News

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