Regulatory

Venus Medtech’s TAVR Device Is Approved By CFDA, Creating A New Era Of Interventional Cardiology In China

HANGZHOU, China, April 28, 2017 /PRNewswire/ — Venus Medtech (Hangzhou) Inc., announced on April 25th that its transcatheter aortic valve system – Venus A-valve – has been approved by China Food and Drug Administration(“CFDA”) (registration no.: 20173460680) for sale in China. […]

Cardiac Insight Announces FDA Clearance of “CARDEA SOLO™” – The First Wearable (ECG) Sensor Giving Physicians Immediate Access to Complete Cardiac Arrhythmia Data and Analysis

KIRKLAND, Wash.–(BUSINESS WIRE)–Cardiac Insight, a U.S. developer of body worn sensing devices and computational software, announced today, the FDA has cleared the company’s wearable electrocardiogram (ECG) sensor, CARDEA SOLO™. The device offers physicians immediate access to improved reporting and analysis […]

Cordis, a Cardinal Health Company, introduces innovative products at EUROPCR 2017 to rapidly expand interventional cardiology offering

PCRonline/News/Industry Press Releases – 15 May, 2017 DUBLIN, Ohio. Cordis, Cardinal Health‘s interventional vascular business, announced today the commercial launch of three new products that further enhance its interventional cardiology product portfolio in Europe, the Middle East, and Africa (EMEA). The […]

Surgery Without the Knife: Mirabilis Medical Announces European Approval for Non-Invasive Uterine Fibroid Treatment

BOTHELL, Wash., March 23, 2017 /PRNewswire/ — Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union.  The company […]