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.
Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7
Insulet (Nasdaq: PODD)+
today announced a new integration for its Omnipod 5 platform, building on its partnership with Dexcom (Nasdaq: DXCM)
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.
IceCure Receives Notice of Patent Allowance in U.S. for a Novel Cryogen Flow Control to Optimize Patient Outcomes
IceCure has 20+ patents in the U.S. and the Company anticipates further market traction upon FDA’s marketing authorization decision in early-stage breast cancer
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.
Olympus launches AI-powered emphysema screening tech
Olympus announced today that it has fully launched its AI-driven emphysema screening program, SeleCT Screening.
Solventum Launches Preassembled, See-through VH2O2 Test Pack for Low-temp Medical Instrument Sterilization
ST PAUL, Minn., June 9, 2025 /PRNewswire/ — Solventum, a global MedTech leader at the forefront of infection prevention innovation, today announced the launch of its Attest™ Super Rapid Vaporized Hydrogen Peroxide (VH2O2) Clear Challenge Pack. The ready-to-use test integrates two previously FDA-cleared indicators – a biological indicator (BI) for confirming microbial neutralization and a chemical indicator (CI) for verifying proper sterilizer function – into a single-use test pack with a transparent container.
Engineers develop portable device to detect rare mutations
A team led by Rutgers University-New Brunswick engineers has developed a portable device capable of detecting rare genetic mutations from a single drop of blood.