APYX - Apyx Medical sinks on safety concern for product technology

Medical device maker Apyx Medical Corporation (APYX -21.2%) is trading sharply lower on Monday after the company warned that the U.S. Food and Drug Administration (FDA) flagged potential safety issues linked to its Advanced Energy products. According to Apyx (NASDAQ:APYX), the FDA has issued a so-called Medical Device Safety Communication to warn health care providers, patients, and consumers about a potential safety concern related to Advanced Energy products. Backed by its Renuvion product sold in the cosmetic surgery market, the company’s Advanced Energy segment generated ~88% of its top line in the first nine of 2021. The technology is marketed and sold as J-Plasma in the hospital surgical market. Citing initial talks with the FDA, Chief Executive Charlie Goodwin noted that the issue could be linked to the use of the products outside of an FDA-cleared indication. “While we are aware that some of our products are being used by

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Apyx Medical sinks on safety concern for product technology