Gentherm Medical Receives FDA Clearance for ThermAffyx™ Patient Safety System

Gentherm announced FDA 510(k) clearance for its ThermAffyx Patient Safety System, a patented integrated device combining active patient warming, securement, and pressure reduction for robotic-assisted surgical procedures. Product trials begin in August with revenue expected in Q3 2026. The device addresses a critical gap where over 25% of robotic surgery patients experience hypothermia despite current warming interventions.