InMode shares drop after FDA notes ‘risks’ of RF microneedling devices

The U.S. Food and Drug Administration said in a statement that it is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses of radiofrequency microneedling devices. “These devices use an array of small electrodes, also known as microneedles, to deliver RF energy into and under the skin to produce local heating. With use of these devices for dermatologic or aesthetic procedures intended to improve the appearance of the skin, the FDA is aware of reports of serious complications including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries.While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and health care providers to report any complications related to the use of these devices for dermatologic or aesthetic skin procedures to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.” Shares of InMode (INMD), which makes aesthetic medical devices, are down over 1% to $15.35 in morning trading.