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Axonics Receives FDA Approval for Third-Generation Implantable Neurostimulator

February 16, 2021

Via: BioSpace

Axonics Modulation Technologies, Inc., a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation devices for the treatment of urinary and bowel dysfunction, has received PMA supplement approval from the U.S. Food & Drug Administration for its third-generation implantable neurostimulator.

This marks the sixth FDA approval Axonics has received for a significant product innovation since the company’s U.S. commercial launch in November 2019. The FDA previously approved Axonics’ second-generation rechargeable INS in April 2020, which extended the recharge interval to one hour each month.

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