OrthoFix secures FDA and CE Mark approval to its CervicalStim and SpinalStim bone growth stimulators.

Orthofix International N.V. , a diversified, global medical device company, announced FDA and European CE Mark approvals for its next-generation CervicalStim and SpinalStim bone growth stimulators. These Class III medical devices use a low-level pulsed electromagnetic field (PEMF) designed to activate and augment the body's natural healing process, providing patients with a safe, noninvasive treatment option for promoting post-operative spinal fusion.

The CervicalStim and SpinalStim systems available in the U.S. will be accompanied by a new application for mobile devices called Stim onTrack . Designed for use with smartphones and other mobile devices, Stim onTrack provides tools to help patients follow their prescription, including daily treatment reminders and a device usage calendar. The mobile app also includes a first-to-market feature that enables physicians to receive real-time data on how their patients are adhering to their prescribed treatment protocol. Stim onTrack is free and available through the iTunes App Store. In addition to the app, the next-generation bone growth stimulators include patient enhancements aimed at improving fit, comfort and ease of use.

Comment: Bone growth stimulation is the technique of promoting bone growth in difficult to heal fractures by applying a low electrical current or ultrasound to the fracture.