Orthofix earns FDA, CE Mark approvals for bone growth stimulators: 6 key points

Written by Megan Wood | January 09, 2017 | Print  |

Lewisville, Texas-based Orthofix International received FDA approval for its CervicalStim and SpinalStim bone growth stimulators.

Here are six key points:


1. The company also received CE Mark approval for the stimulators.


2. The stimulators, labeled as Class III medical devices, utilize a low-level pulsed electromagnetic field to jumpstart the body's natural healing process.


3. The stimulators are designed to enhance recovery for patients following lumbar and cervical fusion procedures.


4. In the United States, Orthofix offers Stim onTrack in conjunction with the stimulators. A mobile app, Stim onTrack reminds patients of daily treatment as well as includes a device usage calendar.


5. Stim onTrack also provides physicians with real-time data, so they can view how well patients stick to their treatment plans.


6. The North American Spine Society recently issued coverage recommendations for electrical bone growth stimulators.

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