Embecta wins FDA clearance for disposable insulin patch pump
September 3, 2024
Embecta (Nasdaq:EMBC) today entered the insulin patch pump market with a major regulatory milestone.
Embecta (Nasdaq:EMBC) today entered the insulin patch pump market with a major regulatory milestone.
Think Surgical announced that the FDA granted 510(k) clearance for its TMINI miniature robotic system for use with Medacta’s knee systems.
The comprehensive cloud-based platform combines AI diagnostics and detailed measurements for rapid and accurate diagnosis of structural heart disease and heart failure.
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.
SUNRISE, Fla., Aug. 26, 2024 /PRNewswire/ — Obvius Robotics, a medical device company developing an innovative technology platform for democratizing vascular access, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its CERTA Access System for central venous catheterization (CVC).