DENVER, Oct. 06, 2026 (GLOBE NEWSWIRE) -- TSC Life, a global leading medtech company with over 30 years of redefining healthcare with high-performance solutions for temperature management and endoscopy, announced today that the U.S. Food and Drug Administration has cleared its Mistral-Air® MA1400 Forced-Air Warming System.
The FDA clearance enables TSC Life to market the Mistral-Air® MA1400 in the United States, expanding the company’s temperature management portfolio with a brand-new forced air warming system that reaches operating temperatures in less than 30 seconds compared with competing systems that take anywhere from two to five minutes to reach operating temperature.
"This Mistral-Air® MA1400 is a game changer," said José Garcia Muñoz, Global Product Manager of TSC Life. “Preventing a patient’s perioperative temperature drop early is far more effective than trying to correct it later. Mistral-Air® MA1400 is designed to prevent the temperature drop, not chase it, which is why we are so excited about introducing it to the US market. It is small, quiet, and helps clinicians start warming sooner, supporting compliance with perioperative warming protocols from the very beginning.”
Why early patient warming matters
Core body temperature can begin falling shortly after the induction of anesthesia as heat redistributes away from the body’s core into the periphery. This early temperature loss can occur before active warming becomes a focus of the surgical team.
Perioperative hypothermia, including mild hypothermia, has been associated with patient discomfort, increased blood loss, impaired coagulation, increased infection risk and prolonged recovery. Clinical guidelines worldwide recommend early and consistent temperature management but maintaining that consistency can be challenging in the fast-paced environment of the operating room.
The Mistral-Air® MA1400 is designed around this challenge, helping clinicians initiate warming quickly and incorporate temperature management into the workflow from the beginning of a case.
Fast, Quiet, and Clean – means it’s better for patients and their caregivers
The Mistral-Air® MA1400 reaches operating temperature in under 30 seconds, allowing active warming to begin quickly before and during the early phase of anesthesia.
The system features a default startup temperature of 38 ℃, display-free interface and three-button design, helping streamline setup and operation without adding unnecessary complexity to the clinical workflow.
Weighing just 9.7 lbs, the Mistral-Air® MA1400 is designed for easy placement and movement within busy operating room environments. Its 48 dB low-noise operation is intended to minimize disruption during critical phases of patient care.
The system also incorporates HEPA H13 filtration, which captures ≥99.95 % of airborne particles in accordance with applicable European standards. An IP21-certified design, 2,000-hour filter and seven-year expected lifetime are designed to support long-term reliable performance in demanding clinical environments.
"Temperature should not be treated as a background task," Garcia Muñoz said. "It is one of the variables in theater you can control from the very beginning, and the first 30 minutes are where that control matters most."
Designed for the Perioperative Journey
The Mistral-Air® MA1400 is supported by a broad portfolio of Mistral-Air® blankets and warming suits designed for different procedures, patient positions and surgical access needs. Proprietary silver reflective blankets combine forced-air warming with passive insulation to help retain warmth throughout surgery and even during patient transport.
The Mistral-Air® MA1400 builds on TSC Life’s established temperature-management portfolio, which includes Fluido® blood and fluid warming systems, featuring a simple and portable warming cassette with low priming volume that moves with the patient. The FDA clearance of Mistral-Air® MA1400 marks another step in TSC Life’s continued expansion in the U.S. market.
About TSC Life
TSC Life is a global medtech company based in the Netherlands with more than 30 years of experience in developing, manufacturing, and delivering healthcare solutions to hospitals and care facilities worldwide. The company is redefining healthcare with high-performance solutions for patient temperature management and endoscopy, including Mistral-Air® forced air warming systems, Fluido® blood and fluid warming systems, and Broncoflex® single-use bronchoscopes - each engineered to be brilliantly simple while ensuring efficient, high-quality patient care that supports evidence-based outcomes.
Caution: Federal law restricts this device to sale by or on the order of a physician.
FOR MORE INFORMATION:
Contact customer service at (765) 205-6030, cs.us@tsc-life.com www.tsc-life.com
US Media Relations: Dave Rawlings | dave.rawlings@tsc-life.com
Or Bill Atkinson |bill@atkinsonstrategic.com |443-797-4150
Photos accompanying this announcement are available at:
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