Baebies Receives FDA Breakthrough Device Designation for First Point-of-Care Heparin Monitoring Test

April 23, 2025
10:59 pm

DURHAM, N.C., April 23, 2025 /PRNewswire/ -- Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Anti-Factor Xa test on the FINDER® platform —the first point-of-care heparin monitoring assay. Designed for patients receiving unfractionated or low molecular weight heparin, the test provides results in under 15 minutes from just 50 µL of whole blood. This designation recognizes the test's potential to bring heparin monitoring closer to the patient, enabling faster and more effective dose management in critical care settings.

“This designation provides priority FDA review and dedicated regulatory guidance, accelerating our efforts to bring the test to market,” said Richard West, Founder and CEO of Baebies. “It positions FINDER® to expand rapidly into the multi-billion-dollar coagulation testing space.”

Heparin dosing requires tight control to prevent both bleeding and clotting complications. In high-risk settings such as extracorporeal membrane oxygenation (ECMO), mortality rates are often around 50%, and bleeding occurs in over a third of patients. Anti-Factor Xa tests—the preferred method for guiding therapy—are confined to central labs and often take over an hour, delaying time-sensitive dosing.

Baebies Receives FDA Breakthrough Device Designation for First Point-of-Care Heparin Monitoring Test

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