Using “acoustic shock waves” to promote healing isn’t just for Overwatch, as Sanuwave has obtained FDA approval for its Dermapace System (Pulsed Acoustic Cellular Expression = PACE). Its approval is specifically to help heal foot ulcers in diabetic patients, where damage to blood vessels and nerves can lead to reduced circulation, infection and sometimes amputation. The Dermapace mechanically stimulates the wound, which Sanuwave says promotes healing. Like several other “first” FDA approvals we’ve seen recently, this device went through the de novo review process designed specifically to get new technology on the market.
After two double-blind studies, the results showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate with the real Dermapace device, vs. a 30 percent closure rate for patients treated with a fake system. Now that this device has been approved, it also opens the door for similar technology, if it can show that it’s “substantially equivalent.”