Baebies Gets FDA Breakthrough Status for Heparin Monitoring Test

Baebies, a North Carolina-based diagnostics company, has received Breakthrough Device Designation from the US 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.

“It is rewarding to see our long-standing, NIH-funded collaboration with Baebies achieve FDA breakthrough,” said Dr. Sitaram Emani, Associate Professor of Surgery at Harvard Medical School. “I look forward to the test supporting timely anticoagulation decisions and advancing heparin management.”

Unlike existing tests, the FINDER Anti-Factor Xa Test requires no centrifugation and can be run directly at the point of care or in a central lab, delivering results in minutes. It addresses a life-threatening condition, offers significant advantages over existing methods, introduces breakthrough technology where no cleared alternatives exist, and serves the best interest of patients—meeting the FDA Breakthrough Device criteria.

“We’re growing beyond our paediatric roots to serve broader populations by bringing multifunctional diagnostics to patients of all ages, wherever care is delivered,” said Vamsee Pamula, PhD, founder and president of Baebies.

Baebies is a diagnostics company headquartered in Research Triangle Park, North Carolina. With over 22 million tests delivered globally, Baebies is a technology leader that pioneered digital microfluidics (DMF). Its multifunctional FINDER platform supports chemistry, immunoassay, molecular, and coagulation testing from small-volume samples.

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