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 […]
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 […]
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 […]
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 […]
Coming to a Transplant Unit Near You: Drones Impact on the Delivery of Healthcare
BY KEN DROPIEWSKI The FAA predicts there will be 7 million drones registered in the US by 2020. While over half of the drones flying today belong to hobbyists, the rest are owned by private enterprise and various government agencies. […]
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 […]
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 […]
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 […]
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 […]