Regulatory

MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR™ Sirolimus Drug Eluting Balloon

NYON, Switzerland, June 30, 2020 /PRNewswire/ — MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad […]

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

First ICM device with remote programming paired with dual-stage arrhythmia detection algorithm MARLBOROUGH, Mass., June 29, 2020 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with […]

preCARDIA, Inc. Receives FDA Breakthrough Device Designation for Novel, Catheter Based Heart Failure Treatment

Pioneering technology is designed to address Acute Decompensated Heart Failure ST. PAUL, Minn., June 23, 2020/PRNewswire/ — preCARDIA, Inc., has announced that the company’s catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. […]

Philips receives FDA premarket approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators

Amsterdam, the Netherlands and Cambridge, MA – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 [1] and HeartStart FRx [2] […]

Resverlogix Reaches Agreement With FDA for Key Aspects of Apabetalone Registration Enabling Study

CALGARY, Alberta, June 22, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix”) (TSX:RVX) is pleased to announce that the U.S. Food & Drug Administration (FDA) has accepted its BETonMACE2 clinical plan as a registration enabling study with positive implications for Resverlogix and its ongoing partnership discussions. Key written development points from […]

Canon Medical Receives FDA Clearance for Compressed SPEEDER Technology for 1.5T MR, Enabling Reduced Scan Times

New Software Version for Vantage Orian 1.5T Also Offers Cybersecurity Solutions to Protect Patient Data TUSTIN, Calif.–(BUSINESS WIRE)–Hospitals and institutions are continually looking for ways to improve diagnostic imaging throughput, especially in today’s environment where disinfection of systems and rooms in between patients is crucial. Now, with the newly FDA-cleared […]

MIVI Neuroscience Announces FDA IDE Clinical Study Approval For the MIVI Q Aspiration Catheter

EDEN PRAIRIE, Minn., June 9, 2020 /PRNewswire/ — MIVI Neuroscience, a leading developer, and marketer of precision stroke therapy devices utilized by neurointerventionists around the world, announced today that the FDA has determined the company has provided sufficient data to support initiation of a human clinical study of the MIVI Q Aspiration Catheter […]

FDA Approves Abiomed’s First-in-Human Trial of Impella ECP, World’s Smallest Heart Pump

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP™ heart pump. Impella ECP, which stands for expandable cardiac power, will be […]

Novadoz Pharmaceuticals FDA Approvals of Oseltamivir and Dofetilide Continues the Company’s Rise in the Generic Market

PISCATAWAY, N.J., June 4, 2020 /PRNewswire/ — Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, located in Hyderabad India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules and Dofetilide Capsules. The company was notified earlier this year, that Dofetilide 125mcg, 250mcg, 500mcg capsules, AB rated to […]

FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP. Impella RP is a temporary heart pump that provides circulatory support for […]