MedTech News

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

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.

Read More »

CGBIO Receives FDA IDE Approval for NOVOSIS PUTTY, Advancing Toward U.S. Market Entry

SEOUL, South Korea, April 23, 2025 /PRNewswire/ — CGBIO(CEO Hyun Seung Yu), a leading Korean company specializing in bio-regenerative medicine, proudly announces that its innovative bone graft substitute, NOVOSIS PUTTY, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This pivotal approval paves the way for a clinical trial in spinal fusion procedures within the United States.

Read More »

Sign up for Blog Updates