MedTech News
Dexcom submits 15-day CGM to FDA, beats Street in Q3
Dexcom’s third-quarter earnings report included news of a significant submission to the FDA for the company’s latest-generation technology.
Medtronic wins CE mark for Evolut FX+
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Evolut FX+ transcatheter aortic valve implantation (TAVI) system.
World’s First Robotic Surgery Using Meta Quest and 3D Visualization Demonstrate a Real-World Application of Augmented Reality (AR)
MOUNTAIN VIEW, Calif., Oct. 24, 2024 /PRNewswire/ — In a groundbreaking advancement for medical science, surgeons in Santiago, Chile, performed the world’s first robotic surgeries combining 3D visualization and augmented reality (AR), marking a significant step forward in improving surgical speed, visualization, precision, and patient outcomes.
Sky Labs’ Ring Based Blood Pressure Monitoring Device Recognized for High Accuracy by the International Society of Hypertension
SEOUL, South Korea, Oct. 24, 2024 /PRNewswire/ — Sky Labs’ CART BP, an innovative blood pressure monitoring device, has been recognized by the International Society of Hypertension (ISH) for its exceptional accuracy in both day and night measurements.
FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter
Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter.
Luna Diabetes launches trial for ‘world’s smallest insulin patch pump’
Luna Diabetes says it has launched a pivotal trial for what it describes as “the world’s smallest insulin patch pump.”
iRhythm’s Zio AT design changes win FDA clearance
The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT)+
announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB).