Innovative endovascular treatment for communicating hydrocephalus gains regulatory support for patients aged 12 and older.

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.

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.

Epiminder announced today that it received FDA de novo authorization for its implantable continuous electroencephalogram monitoring (iCEM) system.

NeuroOne (Nasdaq:NMTC) announced today that it filed an FDA 510(k) submission for its trigeminal nerve ablation technology.

Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy.

Medtronic (NYSE:MDT) announced that the FDA approved its Simplera Sync continuous glucose monitor for use with the MiniMed 780G.

BVI Medical announced that it received FDA 510(k) clearance for its Leos (laser endoscopy ophthalmic system) for treating glaucoma.

New implants aim to enhance outcomes in foot and ankle surgeries through advanced material technology.

Precision Neuroscience announced today that it received FDA 510(k) clearance for its Layer 7 cortical interface for BCI technology