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Home » Orthofix’s AccelStim Bone Healing Device Gains FDA’s Premarket Approval
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.
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