MedTech News

Medtronic receives FDA clearance for Visualase V2 MRI-guided laser ablation system

Medtronic has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Visualase V2 MRI-Guided Laser Ablation System. This milestone brings important capital system enhancements to the Visualase platform, which provides a minimally invasive surgical option for patients with focal epilepsy, brain tumors, and radiation necrosis, which impacts over 1 million people total worldwide.

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Microtech Announces the First U.S. Atrial Microsensor Implantations as Part of its FIH Study

TEL AVIV, Israel, June 9, 2025 /PRNewswire/ — Microtech, a wholly owned subsidiary of Medinol, is happy to announce the first U.S. implantations of its atrial-pressure microsensor. Two surgical implantations were performed on Friday, May 16, 2025, at New York-Presbyterian/Columbia University Irving Medical Center by Dr. Koji Takeda, Surgical Director for Adult Heart Transplant at New York-Presbyterian/Columbia.

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TYBR Health Announces FDA 510(k) Clearance for B3 GEL™ System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function

HOUSTON, June 9, 2025 /PRNewswire/ — TYBR Health, a medical device and regenerative medicine company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL™ System. B3 GEL™ is a bioresorbable, flowable gel barrier designed to protect healing tissue planes and preserve mobility following surgeries involving tendons, ligaments, and skeletal muscle.

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