Orthofix International N.V. said its PhysioStim bone growth stimulators received U.S. Food and Drug Administration and European CE marking approvals.
The PhysioStim is a class 3 medical device that will serve as an alternative, nonsurgical treatment for patients with nonunion fractures, or bone fractures that do not heal using standard therapies.
The device stimulates bone repair through a pulsed electromagnetic field signal that produces a low-level electrical field at the fracture site. It can be used for treating nonunion fractures in the arm, hand, wrist, clavicle, shoulder, hip, thigh, lower leg, ankle or foot.
