Gentherm wins FDA clearance for surgical patient warming device

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Gentherm Medical Receives FDA Clearance for ThermAffyx™ Patient Safety System

July 20, 2026 4:00 PM EDT

NOVI, Mich., July 20, 2026 (GLOBE NEWSWIRE) -- Gentherm, a global market leader of innovative thermal management and pneumatic comfort technologies, announced today it received FDA 510(k) clearance for its patented ThermAffyx Patient Safety System. This Class II medical device combines active patient warming, securement and pressure reduction in a single platform designed for the more than 3 million robotic-assisted surgical procedures performed annually... More