Regulatory

Medtronic Enrolls First Patient in Study of IN.PACT(TM) AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease

GlobalNewsWire DUBLIN – May 24, 2017 – Medtronic plc (NYSE: MDT) today announced that the first patient has been enrolled in the IN.PACT(TM) AV Access Drug-Coated Balloon (DCB) study for use in patients with end-stage renal disease (ESRD). The U.S. Food and Drug Administration (FDA) approved the investigational device exemption […]

Shockwave Medical Snags CE Mark for Coronary Lithoplasty System

FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty® System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. The Shockwave Medical Coronary Lithoplasty System is an innovative […]

Acutus Medical Snags FDA OK for AcQGuide Steerable Sheath

CARLSBAD, Calif.–(BUSINESS WIRE)–Acutus Medical®, a company committed to transforming the lives of millions of patients with complex arrhythmias, today announced the FDA clearance of the AcQGuide™ Steerable Sheath. The company will also feature several international presentations highlighting the AcQMap® High Resolution Imaging and Mapping System at the Heart Rhythm Society’s […]

Teleflex Inc. (TFX) Wins FDA 510(k) Clearance for the Arrow AC3 Optimus Intra-Aortic Balloon Pump

Teleflex Receives FDA 510(k) Clearance for the Arrow® AC3 OptimusTM Intra-Aortic Balloon Pump (IABP) Advanced IABP performance with the ability to provide optimized therapy to the most challenging patient conditions, even patients with the most severe arrhythmias and heart rates as high as 200 bpm.1 WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: […]

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. This marks the first-ever CFDA approved Transcatheter Aortic Valve Implantation […]

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 of heartbeat-to-heartbeat data. The design and ease of use also […]

Biotricity Files for its Second and Final FDA 510(k) to Bring Bioflux Solution to Market

REDWOOD CITY, Calif., April 12, 2017 (GLOBE NEWSWIRE) — Biotricity, Inc. (OTCQB:BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, has filed for a second and final 510(k) for the hardware portion of its Bioflux solution with the U.S. Food and Drug Administration […]

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 addition of the Cordis RAILWAY Sheathless Access System as well […]