Bioventus Gets 510(k) Clearance for Its StimRouter Pain Management Device

Durham, N.C.-based Bioventus has received 510(k) clearance from the FDA for the latest version of its StimRouter neuromodulation system for treating chronic pain of peripheral nerve origin, excluding craniofacial pain.

The minimally invasive device consists of a thin, implanted lead with a conductive electrode and an external electric field conductor that delivers electric signals to the targeted nerve.

The new version of the system includes a smartphone application and a new external electric field conductor.

Thousands of patients have been successfully treated with a previous version of the StimRouter system, the company said.