Coronary/Structural Heart

Essential Medical Announces IDE Study Results to be Presented in Late Breaking Clinical Science Session at TVT 2018

MALVERN, Pennsylvania, June 18, 2018 /PRNewswire/ — Essential Medical, Inc., a private medical device company focused on innovative solutions for large bore vascular closure, today announced that the results from the SAFE MANTA IDE clinical trial will be presented at the Transcatheter Valve Therapies (TVT) 2018 congress in Chicago June 20-22. Essential Medical’s MANTA™ system is the […]

Bay Labs’ EchoMD AutoEF Software Receives FDA Clearance for Fully Automated AI Echocardiogram Analysis

SAN FRANCISCO – June 19, 2018 – Bay Labs, a medical technology company at the forefront of applying artificial intelligence (AI) to cardiovascular imaging, today announced its EchoMD AutoEF software product received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the fully automated clip selection and calculation […]

CellAegis Announces Completion of Patient Enrollment in UK Investigator Sponsored Clinical Trial using autoRIC® Device

TORONTO, June 14, 2018 (GLOBE NEWSWIRE) — CellAegis Devices Inc. (“CellAegis” or the “Company”), a commercial-stage medical device company advancing innovative, non-invasive, safe and cost-effective solutions for acute and chronic cardiovascular conditions, today announced completion of patient enrollment in a large-scale, investigator-sponsored trial (“ERIC-PPCI”) to further assess the efficacy of […]

Venus Medtech Enters North American Market

HANGZHOU, China and VANCOUVER, Canada, June 14, 2018 /PRNewswire/ — On June 12, 2018, St Paul ‘s Hospital in Vancouver, Canada successfully completed two cases of VenusP-Valve self-expanding pulmonary valve implantation. This is the first appearance of Venus Medtech’s transcatheter valve products in North America. The pace of internationalization continues to move forward. Although surgical treatment of congenital heart disease […]

LivaNova Receives FDA Clearance and Completes First Implant for its MEMO 4D Semi-rigid Mitral Annuloplasty Ring

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced it received FDA 510(k) clearance for its MEMO 4D® semi-rigid mitral annuloplasty ring and confirmed the first implantation of the device. MEMO 4D, LivaNova’s next-generation of the MEMO device family, now offers a broader range of […]

Cardiovascular Research Consortium to Provide Access to Real-World Heart Care Data via the TriNetX Platform

CAMBRIDGE, Mass., June 12, 2018 /PRNewswire/ — The Cardiovascular Research Consortium (CRC), a nationwide network of community-based cardiology practices, has selected TriNetX’s real-world evidence platform to provide the biopharmaceutical industry with the first-of-its-kind access to extensive cardiology-specific clinical data. The data in combination with TriNetX’s advanced analytics capabilities and on-demand access, will enable […]

LivaNova’s Perceval Sutureless Aortic Heart Valve Approved in Japan

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced that Japan’s Ministry of Health, Labour and Welfare has approved the Company’s Perceval® sutureless aortic heart valve to treat aortic valve disease. “With this approval for Perceval, an innovative and trusted valve platform, we are able […]

Celixir announces US FDA approval of the IND application for cell therapy Heartcel

Stratford-upon-Avon, UK, 08 June 2018 – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced […]

Corindus Announces Pharmaceutical and Medical Device Agency (PMDA) Approval of CorPath GRX System in Japan

WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a leading developer of precision vascular robotics, announced today that it received Pharmaceutical and Medical Device Agency (PMDA) Approval for commercialization of its CorPath® GRX System in Japan. Japan is one of the largest markets in the world for percutaneous coronary interventions […]

Acasti Pharma to Present at the XVIII(th) International Symposium on Atherosclerosis

LAVAL, Québec, June 06, 2018 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (NASDAQ:ACST) (TSX-V:ACST) (the “Company” or “Acasti Pharma”), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that the Company is scheduled to […]