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

Adagio Medical (Nasdaq:ADGM) announced today that it received FDA breakthrough device designation for its vCLAS cryoablation system

SAN FRANCISCO, April 17, 2025 /PRNewswire/ — Solo Pace Incorporated, an emerging medical technology company, announced both FDA Clearance and First-In-Human use of their SoloPace Control System for temporary pacing in Transcatheter Aortic Valve Replacement (TAVR) procedures. With standardized workflows, the Control System is engineered to improve TAVR temporary pacing efficiency and reduce patient risks. Initial cases were completed this month at Scripps Clinic by Chief of Cardiology, Paul Teirstein, MD and Curtiss Stinis, MD.