DENVER, February 3, 2026 — Leads & Copy —
TSC Life, a global medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its Fluido® Compact Fluid Warming System for pediatric use.
The Pediatric Indication allows TSC Life to market the system to hospitals specifically for pediatric patients in the U.S. and Canada.
According to Chris Duffie, U.S. Commercial VP, the FDA clearance recognizes the safety and benefits of the fluid warming system for the pediatric population, critical patients at risk for hypothermia during surgery. Duffie said the company is excited to bring Fluido® Compact to clients in the U.S. and Canada, calling it a high-quality, reliable system that has been available in Europe and other parts of the world for over 10 years, with more than 10,000 units installed globally.
Market adoption and usage in the U.S., Europe and elsewhere has shown the effectiveness of blood and fluid warmers in pediatric care, demonstrating their ability to maintain safe temperatures and reduce the risk of hypothermia. Body temperature may decrease within 60 minutes of anesthesia, even during brief surgical procedures.
Maintaining normothermia during surgery can prevent complications such as surgical site infections (SSI), coagulopathy, and adverse cardiac events. Neonates and pediatric patients have different thermoregulatory needs and risks, requiring age-specific strategies. Fluido® Compact can be used for pediatric patients and newborns weighing 7.7 pounds (3.5 kilograms) and above.
The Association of periOperative Registered Nurses (AORN) updated its guideline in 2025 on patient temperature management, reinforcing 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.
According to the release, 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.
The Fluido® Compact fluid warming system is designed for use throughout the patient care journey—from the Emergency Department to the Operating Room and into Recovery.
The system offers easy setup, operation and maintenance, low priming volume, portability within the hospital, and normothermic flow rates starting as low as 5ml/min, making it suited for hospitals and clinics looking for a low flow blood and fluid warmer for pediatric and adult use.
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.
TSC Life is a global medtech company based in the Netherlands with over 30 years of experience in developing, manufacturing, and delivering healthcare solutions to hospitals and care facilities worldwide. TSC Life offers Mistral-Air® forced air warming systems, Fluido® blood and fluid warming systems, and Broncoflex® single-use bronchoscopes.
Chris Duffie, U.S. Commercial Vice President, announced that TSC Life received FDA clearance for pediatric use with Fluido® Compact System, a blood and fluid warmer in the U.S. and Canada.
Source: TSC Life
