30 Day Trial

Orthofix Gains FDA and CE Mark Approvals for PhysioStim

Share:

Orthofix gained FDA premarket approval and approval under the CE Mark in the EU for next-gen PhysioStim™ bone growth stimulators, used as a nonsurgical treatment for nonunion fracture in the extremities.

The Class III device emits a pulsed electromagnetic field signal at the fracture site to stimulate bone healing, and is complemented by the STIM onTrack™ mobile app for patient compliance and education.

Orthofix is conducting IDE clinical trials of Physio-Stim in the treatment of knee OA, the RCStim™ system as an adjunct to surgery in the repair of full-thickness rotator cuff tears and Cervical-Stim to treat odontoid fractures.

Sources: Orthofix International N.V.; ORTHOWORLD Inc.