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.
Powerful’s Queen of Heart analyses ECG reads to detect STEMI and STEMI-equivalent patterns indicative of acute coronary syndrome.
StethO Sense, a new Withings+ service powered by eMurmur® and StethoMe, brings on-demand AI-powered heart sound analysis and breathing pattern insights to BeamO users, allowing families to track changes in heart sounds and breathing patterns early from home.
Medtronic (NYSE: MDT) has secured a CE mark for its Endurant stent graft, removing a treatment warning related to its use in ruptured abdominal aortic aneurysms (AAA).
ROTTERDAM, Netherlands, Sept. 3, 2026 /PRNewswire/ — United Imaging has received CE Mark certification for the uCT SiriuX and uCT SiriuX Ultrix, the world’s first dual wide-coverage computed tomography (CT) family, clearing the systems for commercial availability across Europe.