Author: Ken Dropiewski

CardioFocus® Names Burke T. Barrett As Chief Executive Officer

MARLBOROUGH, Mass., Jan. 22, 2020 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that the company’s Board of Directors has promoted Burke T. Barrett to the position of Chief Executive Officer (CEO), effective January 19, 2020. Mr. Barrett previously served as CardioFocus’ President and […]

Teleflex Receives FDA Clearance for Wattson™ Temporary Pacing Guidewire

WAYNE, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the WattsonTM Temporary Pacing Guidewire – the first commercially available bipolar temporary […]

Abbott Reports Fourth-Quarter 2019 Results; Announces Strong Forecast for 2020

– Fourth-quarter sales growth of 7.1 percent; organic sales growth of 8.5 percent – Fourth-quarter GAAP EPS growth from continuing operations of 59.5 percent and adjusted EPS growth from continuing operations of 17.3 percent – Several businesses achieved double-digit sales growth – Forecast reflects continued top-tier sales and earnings growth […]

SEQUANA MEDICAL LAUNCHES EQUITY PLACEMENT

THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 22 January 2020, 15:50  CET Ghent, Belgium, 22 January 2020 – Sequana Medical […]

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 […]