Gentherm has received US Food and Drug Administration (FDA) 510(k) clearance for its ThermAffyx™ Patient Safety System, a Class II medical device designed to improve patient safety during robotic-assisted surgical procedures.

The ThermAffyx system combines active patient warming, patient securement and pressure reduction into a single platform. It is intended for use in the more than three million robotic-assisted surgeries performed globally each year. Product trials at healthcare facilities are scheduled to begin in August, with commercial revenue expected to start in the third quarter of 2026.

The device addresses limitations of conventional underbody securement pads, which help prevent patient movement but do not provide active warming. This is particularly important during robotic procedures and surgeries requiring the Trendelenburg position, where a limited body surface area is available for conventional forced-air warming and patients remain at risk of hypothermia.

ThermAffyx integrates active underbody warming into an anti-slip securement pad using Gentherm's proprietary Carbotex® carbon-fibre heating technology. The radiolucent heating element is designed to provide thermal management while supporting patient positioning during surgery.

The FDA clearance expands Gentherm's patient temperature management portfolio and follows the company's 510(k) submission announced earlier this year. The company plans to begin clinical product evaluations before the commercial launch later in 2026.

 

Source: globenewswire.com

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