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US FDA grants 510(k) clearance for Bioventus’ Neuromodulation System

March 2, 2022

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The US Food and Drug Administration (FDA) has granted 510(k) clearance for Bioventus’ StimRouter Neuromodulation System.

The next-generation pain treatment device is designed to treat chronic pain of peripheral nerve origin, excluding craniofacial pain.

StimRouter is a minimally invasive device, which comprises a thin, implanted lead with a conductive electrode, StimRouter Plus Mobile Application and external electric field conductor (E-EFC).

It transmits the electrical signals transcutaneously from the E-EFC and guides to the targeted nerve by the implanted lead.

Read More on medicaldevice-network.com