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 […]
Other News
Journal of Endovascular Therapy Publishes Peer Reviewed Article Highlighting Real-World Use of the Tack Endovascular System®
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the peer- reviewed publication, “Practical Applications of Tack Implants for Infrainguinal Dissection Repair: A Single-Center Experience” currently available online, with the article scheduled to be published in the February 2020 issue of Journal of […]
Endologix, Inc. Comments on Recent FDA Update on Type III Endoleaks with AFX® Endovascular AAA System
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX), a developer and marketer of innovative treatments for aortic disorders, today announced a response to the U.S. Food and Drug Administration (FDA) update regarding Type III endoleaks with the AFX Endovascular AAA System. Dr. Matt Thompson, Chief Medical Officer of Endologix Inc. commented, “On […]
Medtronic Receives FDA “Breakthrough Device Designation” for Developing Fully Implantable Heart Pump
DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development. […]
Toyoda Gosei and EBM Corp. Launch “SupeR BEAT” Medical Simulator Using e-Rubber
KIYOSU, Japan–(BUSINESS WIRE)–Toyoda Gosei Co., Ltd. (TOKYO: 7282) and EBM Corporation1 today launched the “SupeR BEAT” surgical training simulator. This simulator can reproduce the beating of the heart with extreme accuracy using e-Rubber, an innovative material that moves with electricity. The two companies have been collaborating since November 2017 to develop […]
CORRECTING and REPLACING CAPTION FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival
CORRECTION…by Abiomed October 26, 2019 09:15 AM Eastern Daylight Time DETROIT–(BUSINESS WIRE)–Please replace the caption for release dated October 25, 2019 with the accompanying corrected caption. The release reads: FDA POST APPROVAL STUDY DEMONSTRATES TIMELY IDENTIFICATION OF RIGHT HEART FAILURE AND EARLY USE OF IMPELLA RP LEADS TO HIGHER SURVIVAL […]
Corindus Vascular Robotics, Inc. Stockholders Approve Acquisition by Siemens Healthineers
WALTHAM, Mass.–(BUSINESS WIRE)–At a special meeting today, stockholders of Corindus Vascular Robotics, Inc. (“Corindus” or the “Company”) (NYSE American: CVRS) approved the adoption of the Agreement and Plan of Merger (the “Merger Agreement”), dated as of August 7, 2019, by and among Siemens Medical Solutions USA, Inc. (“SMS USA”), Corpus […]
Windtree Therapeutics Provides Business Update
WARRINGTON, Pa., Oct. 25, 2019 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today provided updates on its lead development programs and business operations. “During the third quarter, we made substantive progress in […]
Edwards Lifesciences Reports Third Quarter Results
IRVINE, Calif., Oct. 23, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today reported financial results for the quarter ended September 30, 2019. Third Quarter and Recent Highlights Sales grew 21% to $1.1 billion; underlying1 sales grew 19% TAVR sales grew 26%; […]
Bardy Diagnostics™ Wins the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and Presents at UK Heart Rhythm Congress 2019
SEATTLE, Oct. 24, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that it was selected as winner of the “Remote Monitoring in Arrhythmias” Technology and Innovation Pitch Session held as part of the Digital Health program at the European Society […]



