Therma Bright Inc

Gentherm Submits FDA 510(k) Application for First-of-Kind Patient Warming and Securement System

- Gentherm has submitted a 510(k) Class II premarket notification to the FDA for ThermAffyx Patient Safety System, combining air-free patient warming with securement technology. - The innovative system addresses two critical patient safety concerns during robotic surgery: maintaining patient temperature and preventing patient movement during Trendelenburg positioning. - The device leverages automotive thermal management technology to prevent inadvertent hypothermia, which can dramatically increase the risk of surgical complications. - FDA clearance is expected within the first half of 2026, potentially establishing a new standard of care for surgical patient safety.