Gentherm Gets FDA Clearance for Patient-Safety System
By Kelly Cloonan
Gentherm received Food and Drug Administration clearance for a medical device that aims to both warm and secure patients during robotic-assisted surgical procedures.
The company, which makes thermal-management technologies such as climate-control seats, said Monday the clearance is for its patented ThermAffyx Patient Safety System.
The device integrates underbody warming into an anti-slip securement pad, combining two patient-safety functions into a single system.
Surgical teams have historically had to piece together separate solutions to keep patients warm and prevent movement, particularly in robotic procedures and surgeries that require patients to be tilted in Trendelenburg position, where they lie flat on their backs with their feet elevated above their heads.
The company said it is scheduled to start product trials for ThermAffyx at healthcare facilities in August, and expects to bring in revenue from the device in the third quarter.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
July 20, 2026 16:36 ET (20:36 GMT)
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