Author: Ken Dropiewski

Adagio Medical Announces US FDA Investigational Device Exemption Approval With Conditions To Conduct A Clinical Study For Treatment Of Persistent Atrial Fibrillation Using The Ultra-Low Temperature Cryoablation System

LAGUNA HILLS, Calif., Aug. 19, 2019 /PRNewswire/ — Adagio Medical, Inc. (Adagio), the developer of iCLAS™, the company’s ultra-low temperature intelligent continuous lesion ablation system, announced that it has received an Investigational Device Exemption approval with conditions from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for persistent atrial […]

Merit Medical Announces Appointment of Lynne N. Ward to Its Board of Directors

SOUTH JORDAN, Utah, Aug. 19, 2019 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has appointed Lynne N. Ward to […]

Bardy Diagnostics™ Selected As Finalist For Two MedTech Insight Awards To Be Announced At AdvaMed’s Annual MedTech Conference

SEATTLE, Aug. 19, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that Informa Pharma Intelligence, a leading international healthcare intelligence consultancy, has recognized BardyDx as a finalist in two categories for the 2nd Annual Medtech Insight Awards for “Best Technical Innovation: Diagnostics” and “Best Proof-of-Value of an […]

Philips unveils HeartStart Intrepid with IntelliSpace Connect across Europe and select markets worldwide

Enhanced communication and seamless data sharing capabilities augment clinical and operational efficiencies for patient assessment across emergency care settings Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of the HeartStart Intrepid monitor/defibrillator with IntelliSpace Connect. Created to provide clinical and operational […]

FDA approves new device to improve symptoms in patients with advanced heart failure

SILVER SPRING, Md., Aug. 16, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device […]

Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is […]

Edwards SAPIEN 3 TAVR Receives FDA Approval For Low-Risk Patients

IRVINE, Calif., Aug. 16, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to the treatment […]

MyoKardia Launches 2nd Annual MyoSeeds™ Research Grants Program to Advance Independent Research in Heart Disease

Pre-Application Letters of Intent are Due September 13 for the 2019-2020 Funding Cycle SOUTH SAN FRANCISCO, Calif., Aug. 15, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. today announced the launch of the 2nd Annual MyoSeeds™ Research Grants Program, an initiative to support original, independent research in the biology and underlying mechanisms of cardiomyopathies […]

preCARDIA Enrolls First Patient in Early Feasibility Study

Company initiates the VENUS-HF study in patients with Acute Decompensated Heart Failure (ADHF) ST. PAUL, Minn., Aug. 15, 2019 /PRNewswire/ — preCARDIA, Inc., a medical device company developing innovative technologies for the treatment of acute decompensated heart failure (ADHF), has enrolled the first patient in the VENUS-HF Early Feasibility Study at Tufts Medical […]

Cardax Files Registration Statement for Proposed $15 Million Follow-On Offering

– Maxim Group to serve as sole book running manager on a firm commitment basis – Funds to be used primarily for pharmaceutical development – Concurrent Nasdaq uplisting planned HONOLULU, Aug. 14, 2019 /PRNewswire/ — Cardax, Inc. (OTCQB:CDXI) announced today that it filed a registration statement on Form S-1 with the Securities […]