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Medical Devices / Submissions and Approvals

Axonics Earns FDA Premarket Approval for Sacral Neuromodulation Device

Nov. 18, 2019

Axonics has obtained the FDA’s premarket approval for its sacral neuromodulation system for treating overactive bladder and urinary retention.

The implantable, rechargeable device is the first of its kind to be approved by the FDA, and the only sacral neuromodulation device greenlit for full-body MRI scans without removal.

With the agency’s decision, patients receiving an MRI scan anywhere below the head can avoid additional surgery, as they no longer need to have their neurostimulator removed before they undergo the scan.

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