APYX - Apyx Medical wins FDA nod for Renuvion APR Handpiece in new indication

• Medical tech company Apyx Medical Corporation ( NASDAQ: APYX ) announced Monday that the FDA issued 510(k) clearance to use its Renuvion APR Handpiece in certain soft tissue-related medical procedures.
• Specifically, the new indication for the device covers the delivery of radiofrequency energy and/or helium plasma for the contraction of soft tissues, including subcutaneous tissue.
• Previously, the FDA had granted 510(k) clearance for Renuvion APR Handpiece for certain skin contraction procedures.
• Apyx Medical’s 510(k) submission for Renuvion APR Handpiece remains under the FDA review for use following liposuction when contraction of subcutaneous soft tissues is required.
• “The receipt of this 510(k) clearance further demonstrates the safety and effectiveness of Renuvion, and our commitment to working with the FDA to secure specific clinical indications related to its use,” Chief Executive Charlie Goodwin said.

For further details see: