ThermAffyx™ Patient Safety System
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Gentherm Medical Selects KNB Communications to Amplify News of its Groundbreaking Patient Warming and Securement Device
Prnewswire· 2026-03-10 14:45
Core Insights - Gentherm has partnered with KNB Communications to enhance the visibility of its innovative ThermAffyx™ Patient Safety System, which addresses patient warming and securement during surgery in a single device [1][1][1] Company Overview - Gentherm is a global leader in thermal management and pneumatic comfort technologies, with a diverse product range including automotive climate control systems and medical temperature management systems [1][1] - The company reported annual sales of approximately $1.5 billion in 2024 and secured $2.4 billion in new automotive business awards [1][1] Partnership Details - KNB Communications will serve as the official agency for Gentherm's medical division, utilizing its healthcare communications expertise to support the launch of the ThermAffyx™ system [1][1] - The collaboration aims to create compelling narratives that communicate the significance of Gentherm's innovations to clinicians, investors, and patients [1][1] Product Information - The ThermAffyx™ Patient Safety System is a first-of-its-kind medical device designed to improve patient safety during surgical procedures [1][1] - Gentherm has submitted a 510(k) Class II premarket notification to the FDA for the ThermAffyx™ system, with clearance expected in May [1][1]
Gentherm Announces FDA 510(k) Submission for Innovative Technology Expected to Promote Safer Surgeries and Better Patient Outcomes
Globenewswire· 2026-02-03 13:30
Core Insights - Gentherm has submitted a 510(k) Class II premarket notification to the FDA for its ThermAffyx™ Patient Safety System, which is designed to enhance patient safety during robotic surgeries by maintaining temperature and preventing movement [1][4] Group 1: Product Innovation - The ThermAffyx™ System is the first of its kind to combine air-free patient warming with securement technology, addressing critical patient safety concerns such as hypothermia and unintended movement during surgeries [2][3] - The development of this system was initiated after identifying a significant clinical gap in the market, showcasing Gentherm's commitment to innovation in medical technology [3] Group 2: Market Impact - The introduction of the ThermAffyx™ System is expected to set a new standard of care in operating rooms, potentially improving patient outcomes significantly [3][4] - Gentherm's approach leverages technology from its automotive division, indicating a strategic expansion into the medical device market [3] Group 3: Company Overview - Gentherm is a global leader in thermal management and pneumatic comfort technologies, with a diverse product portfolio that includes both automotive and medical applications [5] - In 2024, Gentherm reported annual sales of approximately $1.5 billion and secured $2.4 billion in new business awards within the automotive sector, highlighting its strong market position [5]