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Reimbursement / Regulatory

Orthofix Gains FDA and CE Mark Approvals for PhysioStim -

Orthofix gained FDA premarket and CE Mark approval for next-gen PhysioStim™ bone growth stimulators, used as a non-surgical treatment 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 International N.V., 3/7/18)