02/03/2026
This week, Gentherm announced the submission of a 510(k) to the FDA for ThermAffyx™, an integrated patient warming and securement system for surgical procedures using Trendelenburg.
What makes ThermAffyx™ different is how it brings these two clinical needs together in one solution. By combining air-free warming with securement technology, the system is designed to help maintain normothermia and prevent patients from slipping, particularly in robotic and minimally invasive surgeries, where the available surface area on a patient for effective warming is extremely limited.
The system was developed in direct response to customer and clinician feedback, using proven thermal technology adapted from Gentherm’s automotive innovation.
When cleared, ThermAffyx™ has the potential to meaningfully improve surgical outcomes by reducing risks associated with perioperative hypothermia while supporting safer patient positioning in today’s most advanced OR environments.
FDA clearance is expected in the first half of 2026.
https://ir.gentherm.com/news-releases/news-release-details/gentherm-announces-fda-510k-submission-innovative-technology