USFDAJul 20, 2026, 04:02 PM
Gentherm Receives FDA 510(k) Clearance for ThermAffyx Patient Safety System
AI Summary
Gentherm announced it received FDA 510(k) clearance for its patented ThermAffyx™ Patient Safety System, a Class II medical device. This system integrates active patient warming, securement, and pressure reduction into a single platform for robotic-assisted surgical procedures. Product trials are set to begin in August, with revenue generation anticipated to start in Q3 2026, significantly expanding the company's medical product offerings.
Key Highlights
- FDA 510(k) clearance received for ThermAffyx™ Patient Safety System.
- Class II medical device for robotic-assisted surgical procedures.
- Combines active patient warming, securement, and pressure reduction.
- Product trials scheduled to begin in August.
- Revenue generation expected to commence in Q3 2026.
- Utilizes Gentherm's proprietary Carbotex® carbon-fiber heating technology.
- Expands company's patient temperature management portfolio.
Price Impact
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