Other News

Endotronix Joins American Heart Association’s Center for Health Technology & Innovation to Broaden the Use of Guideline-Based Care for Heart Failure Patients

LISLE, Ill., June 28, 2018 /PRNewswire/ — Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced they have joined the American Heart Association’s Center for Health Technology & Innovation’s (CHTI) Innovators Network. The collaboration allows Endotronix to integrate the Association’s digital resources into the Cordella™ 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 […]

Endologix Reports Positive 1-Year Results from the Ovation® LUCY Study

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced 1-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) registry as reported on Saturday, June 23rd at the 2018 Society for Vascular Surgery Annual Meeting. The LUCY study […]

Embolx Announces FDA Clearance of Next Generation Sniper Balloon Occlusion Microcatheter to Deliver Pressure-Directed Therapy for Tumors, Enlarged Prostate and Fibroids

SUNNYVALE, Calif.–(BUSINESS WIRE)–Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its next generation family of Sniper® Balloon Occlusion Microcatheters, an innovative system for pressure-directed arterial embolization therapy. […]

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 […]

Avenu Medical Receives FDA Approval for Ellipsys Vascular Access System for Non-Surgical Dialysis Fistula Creation

SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Avenu Medical, Inc. announced today that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. […]