Other News

CARMAT Announces FDA Full Approval to Initiate US Clinical Feasibility Study of Its Total Artificial Heart

CARMAT has responded to all remaining questions from the conditional approval Number of subjects to be enrolled in the study extended to 10 patients PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for […]

Imricor Announces First Cases Successfully Performed at Heart Center Dresden

MINNEAPOLIS & DRESDEN, Germany–(BUSINESS WIRE)–Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) is pleased to announce the first procedures using the Company’s products following CE mark of the Vision-MR Ablation Catheter have been performed at the Heart Center Dresden. Three procedures were successfully performed over two days by Dr. Christopher Piorkowski and Dr. […]

Abbott’s In-Development Fully Implantable Heart Pump System Earns FDA’s Breakthrough Device Designation

ABBOTT PARK, Ill., Feb. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS). The FDA launched the Breakthrough Devices Program in 2018 to help expedite the development and review […]

Surmodics Names Nusrath Sultana, MD, as Vice President, Clinical Affairs

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced today Nusrath Sultana, MD, has joined Surmodics as Vice President, Clinical Affairs, effective February 3, 2020. “We are fortunate to have someone of Nusrath’s caliber joining the […]

CardioFocus Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

MARLBOROUGH, Mass., Feb. 4, 2020 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib. This […]

Medtronic Begins New Pilot Study as Part of SPYRAL HTN Clinical Program for Renal Denervation in Hypertension Patients

SPYRAL DYSTAL Study to Evaluate the Effects of RDN Using Fewer, Targeted Ablations to Achieve Meaningful Blood Pressure Reductions DUBLIN, Feb. 04, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity™ Spyral renal denervation (RDN) system […]

Endonovo Therapeutics Reduces Debt

Los Angeles, CA, Feb. 04, 2020 (GLOBE NEWSWIRE) — Endonovo Therapeutics, Inc. (OTCQB: ENDV) (“Endonovo” or the “Company”) is pleased to announce the reduction of current liabilities and restructuring of the balance sheet through the approved modification of the terms of the Preferred C shares. Through the amended terms in the […]

DILIsym Services Partners with Large Pharmaceutical Company to Begin QSP Model Development for Heart Failure

QSP Modeling Project Targeted at Prevention of Heart Failure RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–DILIsym Services Inc. (DSS), a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical efficacy and safety, today announced that it is developing a new component for a QSP model […]

Data Presented at ISET Shows Impressive Revascularization in Chronic Total Occlusions with FLEX Vessel PrepTM System

Minneapolis, MN, January 30, 2020 – VentureMed Group, Inc., a privately-held medical device innovator focused on vessel preparation for interventional treatment of peripheral arterial disease (PAD) and stenoses of arteriovenous (AV) fistulas and grafts, announced data presented at the International Symposium on Intervascular Therapy (ISET) Annual Conference, Jan. 22-24, in […]