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.
Latest Clearance Expands VERAFEYE’s Capabilities as the Company Prepares for Commercial Launch in Early 2027
Clearance brings full cerebral and systemic embolic protection to patients undergoing transcatheter aortic valve replacement (TAVR)
LONDON, Sept. 9, 2026 /PRNewswire/ — Full-Life Technologies (“Full-Life”, the “Company”), a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company’s Investigational New Drug (“IND”) application for [225Ac]Ac-FL-261 and that the program has received Australian Human Research Ethics Committee (“HREC”) approval and completed the Clinical Trial Notification (“CTN”) process with Therapeutic Goods Administration (“TGA”).
This registration marks the Company’s second product authorized in Europe and its first expansion beyond prenatal care into the broader women’s health market
Danish medtech company Ropca will bring its autonomous musculoskeletal ultrasound system to the U.S. after receiving FDA 510(k) clearance
Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter.