Author: Ken Dropiewski

Shockwave Medical to Report Fourth Quarter and Full Year 2019 Financial Results on February 13, 2020

SANTA CLARA, Calif., Jan. 21, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced it will report financial results for the fourth quarter and full year 2019 after market close on […]

FDA Approves Medtronic Micra™ AV, the World’s Smallest Pacemaker Which Can Now Treat AV Block

With FDA Approval, More Patients in the U.S. Are Now Candidates for a Leadless Pacing Option DUBLIN, Jan. 21, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is […]

Biotricity Prepares its Filing for a 510(k) Application for its Advanced ECG Analysis Software

REDWOOD CITY, Calif., Jan. 22, 2020 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, announced today that it is finalizing its FDA filing for its next generation, advanced ECG analysis software with an expectation to file a 510(k) clearance application with the US FDA by end […]

European Commission Grants BioVentrix CE Mark Extension for Revivent TC Less Invasive Ventricular Enhancement Therapy

SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, today announced the extension of its CE Mark for the Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure to May 2024. “The extension of our CE Mark is not only an important […]

Ra Medical Systems Receives FDA IDE Approval to Begin Pivotal Atherectomy Clinical Study

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces approval from the U.S. Food and Drug Administration (FDA) that the Company has provided sufficient data to support initiating an investigational device exemption (IDE) to […]

Ncardia and BlueRock Therapeutics Announce Collaboration Agreement and Licensing of Process Development Technologies for the Manufacture of iPSC-derived Cardiomyocytes

LEIDEN, the Netherlands & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ncardia and BlueRock Therapeutics today announced an agreement covering process development technologies for the manufacture of induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Under the terms of the agreement, Bluerock gains access to Ncardia’s large-scale production processes and intellectual property for the production of iPSC-derived […]

First Study of Thoraguard Digital Drainage System Completed at Stanford University Medical Center

Latest Guidelines to Enhance Patient Recovery after Cardiac Surgery Strongly Recommend: Maintenance of Chest Tube Patency to Prevent Complications OMAHA, Neb.–(BUSINESS WIRE)–Centese, Inc. today announced completion of the first clinical study of its Thoraguard® digital drainage system used in cardiac surgery at Stanford University Medical Center. Thoraguard is the first surgical […]

ASNC AND ASE ANNOUNCE 2020 QCDR DESIGNATION FOR THE IMAGEGUIDE REGISTRY

For ImageGuide Users, ASNC and ASE members, QCDR Status Eases MIPS Reporting Burden Fairfax, VA (January 21, 2020) – The American Society of Nuclear Cardiology (ASNC) and the American Society of Echocardiography (ASE) are pleased to announce that the Centers for Medicare and Medicaid Services have approved the ImageGuide Registry® […]

Novoheart Contracts with Global Pharma to Develop Novel Microplate for High Throughput Drug Screening Using Engineered Human Heart Tissue Strips

New 96-Well Microplates (hvCTS-96) to Further Advance MyHeart™ Platform Capabilities for High-throughput Screening of Compounds on Engineered Human Heart Tissue Strips Novoheart Partners with a Global Pharma to Design and Develop the New Microplate and Will Retain Full Ownership of All IP Novoheart is to Enter a Billion-dollar Market and Generate […]

Additional Ventures Launches Comprehensive Initiative Focused on Innovation in Single Ventricle Heart Defect Research

$5.7 million was awarded to five research institutions as they set out with the goal of accelerating scientific discoveries and development of treatments for single ventricle heart defects PALO ALTO, Calif., Jan. 21, 2020 /PRNewswire/ — Additional Ventures announced the recipients of five “Innovation Funds” today as part of a large-scale coordinated research effort […]