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FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature

Advancing its Going for Zero mission, OMRON innovation makes AFib screening an integral part of the brand’s routine home blood pressure monitoring experience HOFFMAN ESTATES, Ill., Nov. 14, 2024 /PRNewswire/ — In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare…

Johnson & Johnson MedTech Receives FDA Approval for the VARIPULSE™ Pulsed Field Ablation Platform for the Treatment of Atrial Fibrillation

The VARIPULSE™ Platform is the first and only Pulsed Field Ablation (PFA) System in the U.S. fully integrated with the CARTO™ 3 Electro-anatomical Mapping System, driving efficiency, reproducibility and accuracy1 Approval is supported by the admIRE study, where 85% peak primary…

MicroPort NeuroScientific Receives FDA Clearance for Its NUMEN™ Silk in the USA

Washington, USA, 23 October 2024 – On September 30, MicroPort NeuroTech (Shanghai) Co., Ltd., a subsidiary of MicroPort NeuroScientific, received US FDA clearance for the NUMEN™ Silk Coil Embolization System (NUMEN™ Silk), marking its entry into the US market, its second international market after China. NUMEN™ Silk is an upgraded version of the […]

Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis

BOSTON–(BUSINESS WIRE)–Elucid has announced that Noridian will extend coverage for AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ™ image analysis software, beginning December 8, 2024. With this decision, five of the seven Medicare Administrative Contractors (MACs) will soon provide coverage for AI-enabled quantitative coronary plaque analysis, expanding accessibility to over 70 percent of […]

Vesalio Announces Clinical Study Initiative for the Recently Launched pVasc Thrombectomy System and Planned Attendance at TCT, VIVA, and VEITH Meetings

Vesalio Introduces pVasc™ U.S. clinical study initiative to capture real-world data and optimize results for patients suffering from peripheral vascular disease PLANO, Texas, Oct. 25, 2024 /PRNewswire/ — Vesalio, a global thrombectomy company dedicated to advancing patient care across…

HeartFlow Announces Favorable Coverage Determination for Plaque Analysis by Four Medicare Administrative Contractors

Coverage policy improves access to artificial intelligence-enabled plaque analysis providing insights to help physicians guide treatment decisions for patients with coronary artery disease Coverage policy improves access to artificial intelligence-enabled plaque analysis providing insights to help physicians guide treatment decisions for patients with coronary artery disease

Abbott Advances Pulsed Field Ablation Clinical Studies and Launches New Technology to Support Advanced Cardiac Mapping

Enrollment completed ahead of schedule in the global IDE for Abbott’s Volt™ PFA System Global FOCALFLEX trial now underway for Abbott’s TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, receives U.S. Food and Drug Administration…