Gentherm Submits 510(k) Notification for Innovative ThermAffyx™ Patient Safety System to FDA

Gentherm announced a 510(k) submission for ThermAffyx™, an integrated patient warming and securement system for robotic surgeries.

Quiver AI Summary

Gentherm, a leader in thermal management technologies, announced it has submitted a 510(k) Class II premarket notification to the FDA for its innovative ThermAffyx™ Patient Safety System. This system addresses crucial patient safety issues during robotic surgeries, specifically in maintaining appropriate patient temperature and preventing movement, particularly when patients are placed in the Trendelenburg position. The ThermAffyx™ combines air-free warming and securement technology, aiming to reduce the risks of hypothermia and improve surgical outcomes. Gentherm, leveraging its automotive technology, aims to set a new standard in operating rooms with this all-in-one solution. FDA clearance is anticipated in the first half of 2026.

Potential Positives

Gentherm has submitted a 510(k) Class II premarket notification to the FDA for its innovative ThermAffyx™ Patient Safety System, potentially opening a new market for integrated patient warming and securement solutions in medical settings.
The ThermAffyx™ System addresses critical patient safety concerns during robotic surgeries, such as hypothermia and patient movement, positioning Gentherm as a leader in enhancing surgical outcomes and patient care.
Dr. Perrin Jones, an anesthesiologist, has highlighted the product as a "game changer," indicating strong professional endorsement and potential demand within the healthcare community.
The company is leveraging technology from its successful automotive division, showcasing its ability to innovate and adapt existing technologies to meet new market needs, which may drive future growth.

Potential Negatives

Submitting a 510(k) notification does not guarantee FDA clearance, and the uncertainty surrounding the approval process may lead to delays in market introduction.
There is potential criticism regarding the adaptation of automotive technology for medical applications, raising concerns over efficacy and safety in a critical healthcare setting.
The reliance on a single product to address significant patient safety concerns could pose risks if the product fails to perform as expected in practical medical applications.

FAQ

What is the ThermAffyx™ Patient Safety System?

The ThermAffyx™ Patient Safety System is an integrated warming and securement system designed to enhance patient safety during robotic surgeries.

How does the ThermAffyx™ System improve patient safety?

This system combines air-free warming with securement technology to prevent hypothermia and patient movement during critical surgical procedures.

When is FDA clearance expected for the ThermAffyx™ System?

The FDA clearance for the ThermAffyx™ System is anticipated within the first half of 2026.

Who developed the ThermAffyx™ Patient Safety System?

The system was developed by Gentherm engineers after recognizing an unmet clinical need in surgical patient management.

What industries does Gentherm operate in?

Gentherm operates in automotive and medical sectors, providing innovative thermal management and comfort technologies for both fields.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

NOVI, Mich., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Gentherm (NASDAQ: THRM) a global market leader of innovative thermal management and pneumatic comfort technologies, today announced it submitted a 510(k) Class II premarket notification to the U.S. Food and Drug Administration (FDA) for ThermAffyx™ Patient Safety System, an integrated patient warming and securement system.

Two leading patient safety concerns during robotic surgery are maintaining patient temperature and preventing patient movement while on the operating room table. The first of its kind ThermAffyx™ System combines air-free patient warming with securement technology to help prevent both hypothermia and patient movement during procedures where it is common for the patient to be positioned in Trendelenburg. Trendelenburg is a tilted, head-down position that uses gravity to shift organs in the abdomen out of the way, giving the surgeon better access. In surgical settings, inadvertent hypothermia can dramatically increase the risk of surgical complications.

“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.”

This is the newest example of the company leveraging technology from its well-known automotive division to develop new systems for medical use.

"This concept is very intuitive and an exciting opportunity for those of us who spend so much time in operating rooms," says Dr. Perrin Jones, an anesthesiologist in North Carolina. "Taking the technology Gentherm uses in heated seats in cars and adapting it into a medical device that we can put under patients to help them stay warm and secure during surgery, will be a game changer in any operating room."

FDA clearance is expected within the first half of 2026.

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About Gentherm
Gentherm (NASDAQ: THRM) is a global market leader of innovative thermal management and pneumatic comfort technologies. Automotive products include Climate Control Seats (CCS®), Climate Control Interiors (CCI™), Lumbar and Massage Comfort Solutions, and Valve Systems. Medical products include patient temperature management systems. The Company is also developing a number of new technologies and products that will help enable improvements to existing products and to create new product applications for existing and new markets. Gentherm has more than 14,000 employees in facilities across 13 countries. In 2024, the company recorded annual sales of approximately $1.5 billion and secured $2.4 billion in automotive new business awards. For more information, go to www.gentherm.com .