APYX - Apyx files for FDA expanded approval of Renuvion APR Handpiece
- Apyx Medical ( NASDAQ: APYX ) said it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for expanded use of Renuvion APR Handpiece.
- The company is seeking to include a specific indication for the use of Renuvion for coagulation of subcutaneous soft tissues where needed, following liposuction.
- The filing is backed by a clinical study and real-world evidence, according to the company.
- "Importantly, our analysis of Renuvion treatment adverse events, when compared to the real-world evidence gathered for liposuction treatments in the literature review, demonstrated that there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone," said President and CEO Charlie Goodwin.
- APYX +2.40% to $2.99 premarket Feb. 1
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Apyx files for FDA expanded approval of Renuvion APR Handpiece