Gentherm wins FDA clearance for surgical patient warming device

Gentherm (NASDAQ: THRM) announced it received FDA 510(k) clearance for its ThermAffyx Patient Safety System, a Class II medical device that combines active patient warming, securement, and pressure reduction in a single platform intended for use in robotic-assisted surgical procedures.

According to a press release from the Novi, Mich.-based company, product trials at healthcare facilities are scheduled to begin in August, with revenue generation expected to start in Q3 2026.

The device integrates active underbody warming into an anti-slip securement pad, using Gentherm's Carbotex carbon-fiber heating technology. The company said the system is designed to address warming limitations during robotic procedures, including surgeries requiring patients to be positioned in the Trendelenburg tilt. Gentherm cited studies indicating that only 17% to 21% of a patient's body surface area may be available for forced-air warming during such procedures, and that more than one-quarter of robotic surgery patients experience hypothermia in recovery despite warming interventions.

Gentherm said the FDA clearance follows a 510(k) submission announced earlier this year and represents an expansion of its patient temperature management portfolio. The company noted that more than 3 million robotic-assisted surgical procedures are performed annually worldwide.

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