Author: Ken Dropiewski

RapidAI Secures FDA 510(k) Clearance for Groundbreaking AI 3D Head and Neck CTA Imaging: Lumina 3D™

SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D™ by RapidAI—an industry-first, automated 3D imaging reconstruction solution designed to replace manual workflows with an AI-powered approach based on the latest groundbreaking AI technology advances. “Obtaining high-quality […]

Surmodics Announces Successful Early Clinical Use of Pounce™ XL Thrombectomy System, Suitable for Non-Surgical Removal of Thrombi and Emboli from Iliac and Femoral Arteries

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the successful early clinical use of its Pounce™ XL Thrombectomy System. The Pounce XL Thrombectomy System received U.S. Food and Drug Administration (FDA) 510(k) clearance […]

BrightHeart Unveils Breakthrough AI Results at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting, Revolutionizing Prenatal Care

PARIS–(BUSINESS WIRE)–BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, presented two groundbreaking studies during the oral plenary and concurrent sessions on January 30th at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting, held in Aurora, Colorado. As the first major unveiling of the […]

GE HealthCare Invests $138 Million in Cork, Ireland Manufacturing Facility to Address Increasing Contrast Media Demand

anuary 31, 2025 03:00 AM Eastern Standard Time CHALFONT ST. GILES, England–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) today announced a $138 million investment to expand its Carrigtohill, Cork contrast media fill and finish manufacturing site in Ireland. A new state-of-the-art facility on the grounds of the existing site will enable 25 […]

Viz.ai and Illuminate Expand Partnership to Improve Cerebral Aneurysm Patient Care

SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced an expanded partnership with Softek Illuminate, Inc., an industry leader in the development of proprietary natural language processing (NLP) and AI software that discovers at-risk patients from electronic medical records (EMR), assesses disease severity, and […]

Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis

Robust evidence of the clinical benefit of WINREVAIR demonstrated in the STELLAR and ZENITH studies resulted in a loss of clinical equipoise in the HYPERION study January 30, 2025 06:45 AM Eastern Standard Time RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced […]

AngioDynamics Initiates AMBITION BTK RCT and Registry to Advance Treatment for Critical Limb Ischemia

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the start of a Randomized Study of the Auryon Atherectomy System Used in Combination with […]

Rapid Medical™ Announces Enrollment in the First-Ever Study on the Cognitive Benefits of Thrombectomy for Ischemic Stroke Patients-Enabled by Advancements in Endovascular Devices

January 29, 2025 11:05 AM Eastern Standard Time SOUTHLAKE, Texas–(BUSINESS WIRE)–Rapid Medical™, a leading developer of active endovascular devices, announces the first patient enrolled in its COGNITIVE Study–the first to examine a link between mechanical thrombectomy and cognitive improvement. TIGERTRIEVER, the only active stent retriever, may uniquely preserve cognitive function with […]