Recently, A medicinal company specializing in acoustic shock-waves has made a break through during the testing of their own equipment. Sanuwave has obtained FDA approval for its Dermapace System (Pulsed Acoustic Cellular Expression) – The PACE in Dermapace. It’s approval is specifically designed to help heal foot ulcers in diabetic patients, where damage to nerves and blood vessels can lead to reduced circulation and even amputation in dire scenarios.
The Dermapace mechanically stimulates the wound, which Sanuwave says promotes healing. Like several other FDA approvals we’ve seen recently, this device went through a review process designed to specifically get new technology on the market.
After two individual studies, crafted by the company, the results showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate with the real Dermapace device. Versus, a 30 percent closure rate for patients using a “fake” system.
Now that this device has officially been approved, it opens the door for similar technology to step through and make a dent in the medicinal sector, that is, if it can show that it’s substantially equivalent.