Abbott wins FDA approval for Aveir VR Mini ventricular leadless pacemaker
September 15, 2026
Abbott (NYSE: ABT) announced today that the FDA has approved the smallest version yet of its Aveir leadless pacemakers.
Abbott (NYSE: ABT) announced today that the FDA has approved the smallest version yet of its Aveir leadless pacemakers.
Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.
The handheld catheterization device AI-GUIDE, created by Lincoln Laboratory and Massachusetts General Hospital, promises improved health outcomes for injured service members and civilians.
LifeTech Scientific, a Shenzhen, China-based developer of advanced minimally invasive medical devices for cardiovascular diseases and disorders, has received CE MDR certification for its self-developed Yuranos abdominal aortic stent graft system, which is indicated for endovascular repair of infrarenal abdominal aortic aneurysms and can be used in combination with the company’s G-iliac iliac bifurcation stent system and SilverFlow iliac artery covered stent system
With the FDA designate in hand, XCath will further the development of its system that is intended to broaden access to stroke treatment globally.
Breakthrough designation for Nutromics’ namesake patch applies to the wearable platform’s function in vancomycin drug monitoring.
IceCure Medical Ltd. announced that it has received approval, as a Class III medical device, from China’s National Medical Products Administration (“NMPA”) for its ProSense® system and associated cryoprobes.
GRAND RAPIDS, Mich., Sept. 10, 2026 /PRNewswire/ — Shoulder Innovations, Inc. (“Shoulder Innovations”, or “the company”) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the N-22 Humeral Head, a titanium implant option for patients with metal hypersensitivity. Alongside the clearance, the company also announced the product’s full commercial launch.
The FDA’s decision follows a clinical assessment of the Emboliner, including the PROTECT H2H IDE study.
Johnson & Johnson MedTech (NYSE: JNJ) announced today that it has received a CE mark for its Acuvue Oasys Max 2-Week, a new reusable contact lens.