Author: Ken Dropiewski

Philips spotlights smart diagnostic and treatment solutions driving clinical confidence and workflow efficiency at ESC 2021

Company’s innovative, integrated imaging systems, devices, software, informatics and services support greater efficiency, enabling high-quality care for a growing volume of complex cardiac patients Early detection, accurate diagnosis, precise treatment and easy follow-up are enabled by data-driven, streamlined workflows Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader […]

Baylis Medical Announces First Clinical Case Using the VersaCross® Large Access Solution in Canada

TORONTO, Aug. 25, 2021 /PRNewswire/ – Baylis Medical announced today the first clinical use of the VersaCross® Large Access Solution in Canada, to perform a Left Atrial Appendage Closure (LAAC) procedure. The new solution includes the world’s first 3-in-1 radiofrequency (RF) wire paired with a seamless shapeable dilator designed to optimize tissue dilation […]

Renovacor Announces the Appointment of Matt Killeen, Ph.D., as Chief Scientific Officer

Dr. Killeen joins Renovacor from BioMarin where he led the discovery and development of AAV-based gene therapies for inherited cardiac diseases PHILADELPHIA, Aug. 25, 2021 (GLOBE NEWSWIRE) — Renovacor, Inc. (“Renovacor”), an early‑stage biotechnology company developing adeno-associated virus (AAV)‑based gene therapies for devastating cardiovascular and central nervous system diseases resulting […]

Aerami Therapeutics Announces Orphan Drug Designation for Imatinib for the Treatment of Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) affects almost 68,000 patients worldwide, with treatment limited to vasodilators, none of which are disease-modifying Dosing of patients in Phase 1 trial is currently ongoing Plans to enter Phase 2/3 Trials in early 2022 DURHAM, N.C., Aug. 25, 2021 (GLOBE NEWSWIRE) — Aerami Therapeutics, Inc. a […]

Cardior Raises €64M Series B to Advance Clinical Pipeline of RNA Therapeutics to Treat Cardiac Disease

Oversubscribed round enables late-stage clinical development of lead candidate, a micro-RNA-132 inhibitor, in heart failure and further accelerates pipeline expansion HANOVER, Germany–(BUSINESS WIRE)–Cardior Pharmaceuticals, a clinical-stage biotech company developing non-coding RNA (ncRNA)-based therapeutics for patients with cardiac diseases, announced today the closing of a €64 million ($76 million) Series B […]

CARMAT Announces the Second Center Implanting Its Total Artificial Heart in the United States

The implant was performed at UofL Health – Jewish Hospital by University of Louisville physicians within the framework of the U.S. Early Feasibility Study PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by […]

Hyperfine’s Portable MRI System Demonstrates High Accuracy for Detection of Brain Hemorrhage in Study Published in Nature Communications

First-of-its-Kind Swoop System Designed to Offer an Accessible, Affordable Option for Brain Imaging GUILFORD, Conn.–(BUSINESS WIRE)–Hyperfine Inc. today announced results of a study of the company’s FDA-cleared portable magnetic resonance imaging (MRI) device, Swoop™, published in Nature Communications. The study, which was conducted at Yale New Haven Hospital, demonstrated high accuracy […]

Medtronic Announces FDA Approval of Next-Gen TAVR System for Treatment of Symptomatic Severe Aortic Stenosis

Evolut™ FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment DUBLIN, Aug. 24, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut™ FX TAVR system. […]

Medtronic Reports First Quarter Fiscal 2022 Financial Results

Strong Financial Performance on Continued Procedure Volume Recovery and Share Gains from New Product Launches DUBLIN, Aug. 24, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT) today announced financial results for its first quarter of fiscal year 2022, which ended July 30, 2021. Key Highlights Revenue of $8.0 Billion Increased 23% Reported and 19% Organic GAAP Diluted EPS […]

MFDS Greenlights VUNO Med®-DeepCARS™, AI Medical Device for Cardiac Arrest Prediction

SEOUL, South Korea, Aug. 24, 2021 /PRNewswire/ — South Korean artificial intelligence (AI) developer, VUNO Inc. announced today that it has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) for its VUNO Med®–DeepCARS™, an AI medical device for cardiac arrest prediction through vital signs. VUNO Med®–DeepCARS™ is a […]