Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children.

Jupiter Endovascular announced today that the FDA approved an investigational device exemption (IDE) study for its Vertex system.

CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH).

Neuros Medical announced today that it received FDA approval for its Altius direct electrical nerve stimulation system.

CENTER VALLEY, Pa., Aug. 27, 2024 /PRNewswire/ — Aesculap, Inc. (Aesculap), in partnership with Christoph Miethke GmbH & Co. KG (MIETHKE), announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the M.scio® System. This unique, non-invasive, telemetric pressure measurement system is designed to provide continuous access to long-term, intracranial pressure (ICP) monitoring of cerebrospinal fluid (CSF) for the management of hydrocephalus via a permanent, fully implantable sensor.

Clearmind Biomedical announced today that it received FDA 510(k) clearance for its Neuroblade neuroendoscopy system.

AKRON, Ohio, Aug. 23, 2024 /PRNewswire/ — Resivant Medical announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its first two products, Cutiva™ Topical Skin Adhesive, and Cutiva PLUS™ Skin Closure System, which combines an adhesive mesh patch with high-viscosity Cutiva™ liquid adhesive. This achievement represents a significant advancement in medical tissue adhesive and wound closure technology and marks the first major adhesive advancement in over 25 years.