Orthofix Earns FDA Approval, CE Mark for Bone Growth Stimulators

Orthofix received an FDA approval and CE mark for its CervicalStim and SpinalStim bone growth stimulators, the Texas-based company said.

The Class III medical devices rely on low-level pulsed electromagnetic fields to stimulate spinal fusion and trigger the body's natural healing process. The stimulators come with a mobile application to provide real-time data on medication adherence for physicians to ensure patients follow their prescription regimes.

The devices are designed for use in post-operative care following lumbar and cervical fusion surgical procedures.