Coronary/Structural Heart

Edwards Comments On CMS Initiation Of National Coverage Analysis For TAVR

IRVINE, Calif., June 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the announcement by the U.S. Centers for Medicare and Medicaid Services (CMS) about a National Coverage Analysis (NCA) for transcatheter aortic valve replacement (TAVR): CMS […]

Lexington Biosciences Concludes Initial HeartSentry Clinical Study

VANCOUVER, British Columbia, June 27, 2018 (GLOBE NEWSWIRE) — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the completion of the initial HeartSentry study conducted at San Francisco Bay-area Diablo Clinical Research. “We are pleased with the performance of the […]

Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High- sensitivity Access hsTnI Assay

BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay […]

HeartFlow Announces New Commercial Coverage With UnitedHealthcare, Largest Health Insurer in U.S.

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that UnitedHealthcare now covers the HeartFlow® FFRct Analysis, extending access to their 45 million beneficiaries. With this new coverage, more than 235 million people in the United States now have access to the HeartFlow Analysis — significantly advancing HeartFlow’s mission of transforming cardiovascular care. The […]

Advanced Bifurcation Selected to Join MaRs Venture Services

Advanced Bifurcation Systems (“ABS” or the “Company”), a clinical stage medical device company developing an innovative stenting platform which overcomes the limitations of current approaches for the treatment of bifurcation lesions in coronary angioplasties, today announced that ABS, through its wholly-owned Canadian subsidiary, Advanced Bifurcation Systems Canada, Inc. (“ABS Canada”) has […]

MyoKardia Doses First Patient in Pivotal Phase 3 EXPLORER-HCM Trial of Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy

SOUTH SAN FRANCISCO, Calif., June 26, 2018 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced that the first patient has been dosed in the company’s Phase 3 EXPLORER-HCM clinical trial.  The pivotal study is […]

New Prevencio Study Using AI Determines Simple Blood Tests Accurately Diagnose Heart Disease and Predict Adverse Heart Events in Diabetic Patients

KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc. today announces data which indicates its HART CAD and HART CVE tests accurately diagnose Coronary Artery Disease (CAD) and risk for Major Adverse Cardiac Events (MACE) in Diabetic Mellitus (DM) patients. Researchers believe the data, presented on June 24 at the American Diabetes Association 2018 Scientific Sessions, […]

Microbot Medical Strengthens Global IP with Issued Patent in India Covering the Company’s ViRob™ Technology Platform

HINGHAM, Mass., June 25, 2018 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq CM:MBOT), a medical device company specializing in the design and development of transformational micro-robotic medical technologies, today announced that Intellectual Property India has granted patent No. 296369, covering the Company’s ViRob™ technology platform. “This issued patent, coupled with […]

BIOLIFE4D Successfully Demonstrates Ability to 3D Bioprint Human Cardiac Tissue

CHICAGO, June 25, 2018 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today announced it has successfully demonstrated its ability to 3D bioprint human cardiac tissue – specifically, a human cardiac patch. The scientific milestone was accomplished within days […]

Essential Medical Announces Positive Results From the SAFE MANTA Clinical Trial, the First Pivotal Trial for a Dedicated Large Bore Closure Device

EXTON, Pennsylvania, June 25, 2018 /PRNewswire/ — Essential Medical, Inc., a private medical device company focused on innovative solutions for large bore vascular closure, today announced the results from the SAFE MANTA IDE clinical trial, the first pivotal trial for a dedicated large bore closure device. Dr. David Wood, Co-Principal Investigator and founding […]