Medical-device maker Orthofix Medical Inc. on Wednesday said it received U.S. Food and Drug Administration authorization for the sale of an ultrasound device designed to to heal bone fractures.
The Lewisville, Texas, company said it received FDA pre-market approval for its AccelStim bone healing therapy Class III device. The device emits a low-intensity ultrasound signal to stimulate the bone's natural healing process and is intended for use in new fractures and stubborn fractures that haven't healed, the company said.
"We believe that expanding access to patients should help grow the existing $100 million market for fresh fracture [low-intensity ultrasiond] solutions," said Kevin Kenny, prsident of the global spine unit at Orthofix.
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