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Gentherm Receives FDA 510(k) Clearance For Its Patented ThermAffyx Patient Safety System

Jul 20, 2026 · 04:01 PM ET· updated 12h ago

Gentherm, a global market leader of innovative thermal management and pneumatic comfort technologies, announced today it received FDA 510(k) clearance for its patented ThermAffyx™ Patient Safety System. This Class II

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Why It Matters

Gentherm got official permission from the FDA to sell a new safety system called ThermAffyx. This approval shows the company can bring new products to hospitals, which is a step forward for their business.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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