TSC Life Receives FDA Clearance for Pediatric Use with Fluido® Compact System, a Blood & Fluid Warmer, in the U.S. and Canada
DENVER, Feb. 03, 2026 (GLOBE NEWSWIRE) — TSC Life, a global medtech company redefining healthcare with high-performance devices for temperature management and endoscopy, announced today that the U.S. Food and Drug Administration has cleared its Fluido® Compact Fluid Warming System for pediatric use.
The Pediatric Indication allows TSC Life to officially market the system to hospitals specifically for pediatric patients in the U.S. and Canada.
“The FDA’s clearance is a strong recognition of the safety and benefits of this fluid warming system to this vulnerable pediatric population, which are the most critical patients at risk for inadvertent hypothermia during surgery,” said Chris Duffie, U.S. Commercial VP. “We are thrilled to bring Fluido® Compact to clients in the U.S. and Canada. It is a high-quality and reliable system that has been on the market in Europe and many parts of the world for more than 10 years. The Fluido® Compact is a trusted and proven solution, with a global installation base in excess of 10,000 units.”
Clinical Benefits of Fluido® Compact for Pediatric Patients
Over a decade of market adoption and usage in U.S, Europe and elsewhere, have shown the effectiveness of blood and fluid warmers in pediatric care, demonstrating their ability to maintain safe temperatures and reduce the risk of hypothermia. Even brief surgical procedures can lead to hypothermia, as body temperature may significantly decrease within 60 minutes of administering anesthesia.
The importance of maintaining normothermia during surgery to prevent complications such as surgical site infections (SSI), coagulopathy, and adverse cardiac events has been well documented. Age-specific strategies are crucial, as neonates and pediatric patients have different thermoregulatory needs and risks. Fluido® Compact can be used for pediatric patients and newborns weighing as little as 7.7 pounds (3.5 kilograms) and above.
The Association of periOperative Registered Nurses (AORN) updated its guideline in 2025 on effective patient temperature management. AORN’s guidelines “reinforces the importance of active warming methods, such as forced-air warming, over passive insulation. Research demonstrates that active warming is more effective in raising patient temperature and preventing hypothermia, especially during general anesthesia.”
These clinical guidelines reinforce the need for warm fluids: One unit of refrigerated blood or one-liter crystalloid at room temperature can reduce mean body temperature by 0,25 °C. Fluid warming is the only method that produces direct core warming and is recommended for all intraoperative infusions ≥ 500mL in adults.
What Makes Fluido® Compact Unique
The name Fluido® Compact speaks for itself. It is a compact fluid warming system designed to accompany patients throughout their entire care journey—from the Emergency Department to the Operating Room and into Recovery.
- Fluido® Compact is a uniquely suited solution for hospitals and clinics looking for a low flow blood and fluid warmer for pediatric and adult use, offering easy setup, operation and maintenance, low priming volume, portability within the hospital, and normothermic flow rates starting as low as 5ml/min.
In early 2025, TSC Life transitioned from relying on Stryker to distribute its Mistral-Air® forced air blanket warming portfolio to building its own direct commercial team in the U.S. market. This shift has accelerated company expansion, strengthened customer relationships, improved U.S. customer care, and opened the door for product introductions like Fluido® Compact to the U.S. market. For more information, visit www.tsc-life.com.
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 devices for 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. The clearance to market Fluido® Compact for pediatric patients highlights TSC Life’s commitment to creating solutions that are intuitive and easy to use, so healthcare providers can focus less on devices and more on their patients.
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
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b5b66769-ddef-4a72-9937-293d32aae6a5
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