Other News

ARCA biopharma Updates Special Protocol Assessment Request to FDA for Gencaro Phase 3 Atrial Fibrillation Clinical Trial

WESTMINSTER, Colo., Dec. 20, 2018 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has submitted an amendment to its Special Protocol Assessment (SPA)request to the U.S. Food and Drug Administration (FDA).  The amendment addresses […]

CathWorks FFRangio™ System Receives U.S. FDA Clearance

KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]

Acasti Pharma Achieves Planned Enrollment Targets for TRILOGY Phase 3 Trials of CaPre® in Patients with Severe Hypertriglyceridemia

LAVAL, Québec, Dec. 20, 2018 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), 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 (HTG), today announced it has reached […]

iRhythm Technologies to Present at the J.P. Morgan 37th Annual Healthcare Conference

SAN FRANCISCO, Dec. 19, 2018 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital health care solutions company focused on the advancement of cardiac care, today announced the company will be participating in the upcoming J.P. Morgan 37th Annual Healthcare Conference in San Francisco, CA. iRhythm’s management is scheduled to […]

Paragonix Technologies, Inc., Announces 510(k) Clearance Allowing for Use of the Paragonix SherpaPak™ Cardiac Transport System with Pediatric and Small Donor Hearts

BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that it received clearance by the Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak™ Cardiac Transport System (CTS)1,2 with small and pediatric donor hearts. Starting in Q1 2019, Paragonix SherpaPak™ CTS will now be shipped with […]

HeartGuide, the highly-anticipated first wearable blood pressure monitor from Omron, available for pre-order on December 20th

LAKE FOREST, Ill., Dec. 20, 2018 /PRNewswire/ — Omron Healthcare, the number one doctor and pharmacist recommended blood pressure monitor brand, will open pre-orders for its new HeartGuide™, the first wearable blood pressure monitor, on December 20th at 12:00pm EST in the United States on OmronHealthcare.com. HeartGuide, an oscillometric blood pressure monitor in the design of a wrist watch, […]

InspireMD Announces Publication of Meta-Analysis Citing Benefits of Next Generation Mesh-Covered Carotid Stent Systems

TEL AVIV, Israel, Dec. 18, 2018 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced the publication of a meta-analysis of four clinical studies involving dual layered and […]

Innovative Cardiovascular Solutions Raises $8M in Series C Financing

KALAMAZOO, Mich., Dec. 18, 2018 /PRNewswire/ — Innovative Cardiovascular Solutions, LLC (ICS), a privately-held clinical stage company developing the Emblok™ Embolic Protection System, today announced the completion of a Series C round of financing, raising a total of $8M. Proceeds from this round will support clinical trials in the U.S. and Europe as well as manufacturing […]

Cardiva Medical Announces FDA Approval of the VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure Following Electrophysiology Procedures

SANTA CLARA, Calif.–(BUSINESS WIRE)–Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that the company has received PMA approval from the U.S. Food and Drug Administration (FDA) for the VASCADE® MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed […]

Merit Medical Acquires Assets of Vascular Insights, LLC

SOUTH JORDAN, Utah, Dec. 17, 2018 (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, today announced that it has acquired substantially all of the […]