Regulatory

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 […]

Cardiovascular Systems Snags FDA Nod for Its Diamondback 360 Coronary Orbital Atherectomy System (OAS)

Cardiovascular Systems, Inc. Receives Approval for the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown in the United States OAS Micro Crown Approved to Treat Severely Calcified Coronary Lesions Only Atherectomy Device Designed to Both Pilot Tight Lesions and Treat Up to 4mm Vessels with a Single Device ST. […]

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 simultaneously announced that it had received approval from the US […]

AngioDynamics Receives CE Mark Certification for The Solero Microwave Tissue Ablation System

ALBANY, N.Y., March 14, 2017 (GLOBE NEWSWIRE) — AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology/surgery, today announced it has received CE Mark certification for the Solero Microwave Tissue Ablation (MTA) System. The Solero MTA System and Accessories are […]

Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HUMACYL® in Vascular Access for Hemodialysis

Press Release RESEARCH TRIANGLE PARK, N.C. — Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted HUMACYL®, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate […]