Gentherm submits 510k Class II premarket notification to FDA

Gentherm (THRM) announced it submitted a 510(k) Class II premarket notification to the U.S. Food and Drug Administration, FDA, for ThermAffyx Patient Safety System. “Gentherm engineers began development after identifying this unmet clinical pain point and gap in the market,” confirmed Steve Fletcher, Senior Vice President and General Manager, Gentherm Medical. “Until now, there hasn’t been an all-in-one product that successfully resolves these patient safety concerns. Our innovation will define a new standard of care and improve patient outcomes.”