Coronary/Structural Heart

Singulex Receives New, Broad Patent for Highly Sensitive Methods for Analysis of Troponin

ALAMEDA, Calif.–(BUSINESS WIRE)–Singulex announced today the granting of a significant European patent (EP 3168618) covering methods for determining myocardial infarction using any high sensitivity cardiac troponin assay with a sensitivity < 5 pg/mL. “The global clinical market is rapidly adopting high sensitivity cardiac troponin assays to better manage patients suspected […]

Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation

MARLBOROUGH, Mass., Dec. 11, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences’ Sapien 3™ Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages […]

Edwards Comments On U.S. Court Decision

IRVINE, Calif., Dec. 11, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, commented today on a federal jury’s decisions in patent litigation between Edwards and Boston Scientific: The jury awarded $35 million in damages to Boston Scientific for infringement of U.S. […]

Irish Medical Device Start-up Curing Irregular Heart Rhythms Wins the Prestigious ICI Innovation Award

GALWAY, Ireland, Dec. 12, 2018 /PRNewswire/ — An Irish medical device’s company, AuriGen Medical has won the prestigious Global Innovation Award at the ICI conference in Tel Aviv, Israel. ICI is the premier International Conference for Innovations in Cardiovascular Systems. The Global Innovation award attracted entries from the best medical device and pharmaceutical start-ups from […]

Analytics 4 Life® and Actelion Enter Research Agreement to Develop New Diagnostics for Pulmonary Hypertension

RESEARCH TRIANGLE PARK, N.C. & TORONTO–(BUSINESS WIRE)–Analytics 4 Life, a digital health company dedicated to improving existing diagnostic pathways, and Actelion Pharmaceuticals Ltd., today announced a collaborative agreement to investigate the use of Analytics 4 Life’s diagnostic imaging technology in pulmonary hypertension. The first 500-person clinical study has been initiated […]

BioCardia Submits 510(k) Application to FDA for AVANCE Steerable Introducer for Transseptal Access to Heart

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced its 510(k) submission for U.S. Food and Drug Administration (FDA) clearance of the AVANCE™ steerable introducer, designed for introducing various cardiovascular catheters into the heart, including via the left side […]

MyoKardia Reports Positive Data from Phase 1b Single-Ascending Dose Clinical Trial of MYK-491 in Dilated Cardiomyopathy and Systolic Heart Failure Patients

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2018 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of cardiovascular diseases, today announced topline results from the Phase 1b single-ascending dose study of MYK-491.  MYK-491 was generally well-tolerated and increases in cardiac contractility were […]

Shockwave Announces collaboration With Abiomed on Physician Training

SANTA CLARA, Calif., Dec. 11, 2018 (GLOBE NEWSWIRE) — Shockwave Medical, a pioneer in the development and commercialization of intravascular lithotripsy to treat complex calcified cardiovascular disease, today announced an investment and collaboration agreement with Abiomed, Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and […]

Bay Labs Announces Collaboration with Edwards Lifesciences to Utilize AI Software to Improve Heart Disease Detection

SAN FRANCISCO – December 10, 2018 – Bay Labs, a medical technology company at the forefront of applying artificial intelligence (AI) to cardiovascular imaging, announced today a collaboration with Edwards Lifesciences focused on improving the detection of heart disease. The partnership involves multiple initiatives, including the development of new AI-powered […]

HeartFlow Initiates PRECISE Randomized Clinical Trial

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced the start of the Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE) trial. The first patient was enrolled by Michael C. Turner, M.D., at Imperial Health Cardiovascular Specialists in Lake Charles, LA. The PRECISE trial is designed to compare the usual approach of diagnosing […]