Orthofix’s AccelStim Bone Healing Device Gains FDA’s Premarket Approval

Orthofix Medical has received the FDA’s premarket approval for its AccelStim bone healing product, classified as a Class III device.

The device generates a low-intensity pulsed ultrasound signal to stimulate the bone’s natural healing process, delivering a nonsurgical treatment for fresh fractures as well as fractures that have not properly healed.

The Lewisville, Texas-based company plans to launch the product in the U.S. by the end of June.

The Class III designation is for products that present a potentially high risk of illness or serious injury. Ten percent of all medical devices fall under this category.