Shock Wave Therapy Receives FDA Marketing Approval

SANUWAVE Health Inc (Suwanee, GA) announced that its innovative shock wave therapy has received approval for marketing from the US Food and Drug Administration. The decision will allow dermaPACE to be marketed as a Class II Medical Device for the treatment of diabetic foot ulcers (DFUs) in the United States, the world’s largest medical device market.

The novel therapy administers shock wave energy to a DFU over 4 to 8 applications in a 2- to 10-week period. Its noninvasive nature makes the system a safe and effective option for patients. Prior to the decision, the therapy was the focus of 2 FDA-approved investigational device exemption clinical studies. Over 24 weeks at 39 US centers, patients treated with the shock wave therapy showed increased wound healing rates with a < 10% rate of recurrence.

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