Axonics (AXNX) Announces FDA Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

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Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

November 14, 2019 6:00 AM EST

IRVINE, Calif.--(BUSINESS WIRE)--

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (SNM) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (FDA) for the clinical indications of overactive bladder (OAB) and urinary retention.

The FDA premarket approval (PMA) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and... More