Ultrasound developer Misonix of Farmingdale, NY, has filed a 510(k) application with the Food and Drug Administration (FDA) for clearance to market its ultrasonic wound debridement system.
The firm said that in clinical trials in Italy and the U.S. the device performed wound debridement with less bleeding than current debridement methods, and appears to aid in the promotion of rapid healing. The product already has approval through a previous filing of a 510(k) application pertaining to soft-tissue aspiration, Misonix said.
By AuntMinnie.com staff writers
April 21, 2005
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