SOUTH JORDAN, Utah, Nov. 21, 2019 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted Breakthrough Device Designation […]
Regulatory
FDA Grants Breakthrough Device Designation Status for BioVentrix Revivent TC Transcatheter Ventricular Enhancement System for Heart Failure
SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure. Less Invasive […]
Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial
Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annually Millions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28 DUBLIN, […]
Ultromics Receives FDA Clearance for its AI-powered Decision Support System, EchoGo Core
AI automates cardiac analysis helping earlier detection of cardiovascular disease, enabling clinicians to improve patient care and outcomes OXFORD, England, Nov. 14, 2019 /PRNewswire/ — Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for […]
Okami Medical Announces Major Milestones: FDA 510(k) Clearance And Key Patent For The LOBO Vascular Occluder
Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets ALISO VIEJO, Calif., Nov. 4, 2019 /PRNewswire/ — Okami Medical Inc., a medical device company, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and initial launch of the LOBOTM Vascular Occlusion System. […]
GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) Injection for Intravenous Use
Clariscan, approved in more than 55 countries globally with over four million patient doses shipped, is now FDA-approved in the U.S. Expands the GE Healthcare portfolio of contrast media products CHALFONT ST GILES, England–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has approved Clariscan™, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, […]
ANI Announces Plans to Launch Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml) for Ventricular Arrhythmias
BAUDETTE, Minn., Oct. 31, 2019 /PRNewswire/ — ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced that its partner Pharmaceutics International Inc. (Pii) has received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml). ANI plans to launch this currently unavailable drug in December, introducing this critical drug for the treatment of ventricular fibrillation and life-threatening […]
Impulse Dynamics Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System
Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM™ (Cardiac Contractility Modulation) therapy, announced today that it has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart System for […]
The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status
Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices 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 that the United […]
HeartVista Receives FDA 510(k) Clearance for One Click™ Cardiac MRI Package, the First AI-assisted Cardiac MRI Scan Solution
LOS ALTOS, Calif.–(BUSINESS WIRE)–HeartVista, a pioneer in AI-assisted MRI solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration to deliver its AI-assisted One Click™ MRI acquisition software for cardiac exams. Despite the many advantages of cardiac MRI, or cardiac magnetic resonance (CMR), its use […]
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