09:55 AM EST, 02/03/2026 (MT Newswires) -- Gentherm ( THRM ) said Tuesday it submitted a 510(k) Class II premarket notification to the US Food and Drug Administration its integrated patient warming and securement system ThermAffyx.

The system uses air-free patient warming and securement technology to help prevent hypothermia and patient movement during surgical procedures, the company said.

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