BEDFORD, Mass., Sept. 26, 2019 /PRNewswire/ — Access Vascular, a medical device company developing the next generation of intravenous devices from novel biomaterials designed to minimize the risk of bloodstream infection, catheter thrombosis, and vein trauma, announced $6M in new funding from new and existing investors. With this new round, Access Vascular is poised to […]
Author: Ken Dropiewski
BD Announces Leadership Succession Plan
FRANKLIN LAKES, N.J., Sept. 26, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that Vincent A. Forlenza, chairman and CEO, will retire as CEO on Jan. 28, 2020, following the company’s annual meeting of shareholders. Forlenza will continue on the BD board of directors, serving as […]
FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers
MALVERN, Pa.–(BUSINESS WIRE)– The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT¹, an intelligent software assistant from Siemens Healthineers that brings artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant of the new AI-Rad Companion platform, AI-Rad Companion Chest CT […]
CorMatrix® Cardiovascular, Inc. completes enrollment of adult arm of its FDA early feasibility IDE study for the Cor® TRICUSPID ECM® valve for pediatric and adult patients
ATLANTA, Sept. 26, 2019 /PRNewswire/ — CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced it has completed enrollment of the adult arm of its FDA early feasibility IDE study for the Cor® TRICUSPID ECM® cardiac valve* for adults with endocarditis and for pediatric patients with congenital heart valve disease. The Cor® TRICUSPID ECM® valve […]
Ancora Heart Announces Positive Safety and Efficacy Data from Study of First-of-Its-Kind Investigational Heart Failure Therapy
SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced results from an interim analysis of heart failure patients treated in the CorCinch FMR study, a U.S. early feasibility study evaluating the safety of the investigational AccuCinch® Ventricular Repair System designed for the […]
United Biologics, Inc. Appoints John Barnhill as Its President and General Manager
SANTA ANA, Calif.–(BUSINESS WIRE)–United Biologics, Inc., a global leader in silicone vasculature, today announced the appointment of John Barnhill as President and General Manager. As President and General Manager, Mr. Barnhill will guide the company’s commercial advancement and innovation strategies, as well as oversee all financial and operations infrastructure to […]
Abiomed Receives FDA PMA Approval for Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is: Minimally invasive, eliminating the need for a […]
OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent
HONG KONG, Sept. 25, 2019 /PRNewswire/ — OrbusNeich Medical K.K. of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent. The COMBO Plus Coronary Stent is the first drug-eluting stent [DES] to combine the proprietary endothelial progenitor cell […]
Fitbit and FibriCheck Announce Partnership to Deliver CE-Marked Heart Health Detection App to Fitbit Smartwatch Users in Europe
Fitbit users in Belgium, the Netherlands, Ireland and the United Kingdom can use FibriCheck to help detect heart rhythm irregularities like Atrial Fibrillation SAN FRANCISCO–(BUSINESS WIRE)–Fitbit (NYSE:FIT) and FibriCheck, an innovative health screening and monitoring app, today announced a partnership enabling users in Belgium, the Netherlands, Ireland and the UK to […]
U.S. FDA Clears Abbott’s High Sensitivity Troponin-I Blood Test That Aids Doctors in Diagnosing Heart Attacks Faster and More Accurately
Newly cleared diagnostic test could help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women ABBOTT PARK, Ill., Sept. 25, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced that its ARCHITECT STAT High Sensitivity Troponin-I blood test has received clearance from the U.S. Food and Drug Administration […]



