Medtronic submits Hugo soft tissue robot for FDA approval
April 28, 2025
William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.
William Blair analyst Brandon Vazquez said 2025 could be the first year market leader Intuitive Surgical will face meaningful U.S. competition.
Medtronic (NYSE: MDT) announced that it received FDA approval for its OmniaSecure defibrillation lead for right ventricle placement.
Clarius is the first to offer an FDA-cleared AI-powered prostate measurement tool on a handheld ultrasound scanner—empowering primary care and urology physicians to assess patients on the spot without waiting for specialist referrals
LEM Surgical announced that it received FDA 510(k) clearance for its Dynamis robotic surgical system for hard tissue surgery.
ENGLEWOOD, Colo., April 24, 2025 /PRNewswire/ — CIRCA Scientific is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PeriCross™ Epicardial Access Kit (formerly Rook®), a purpose-built solution designed to enable controlled and efficient access to the pericardial space via a subxiphoid approach.
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.