Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation DUBLIN, Sept. 9, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility […]
Regulatory
PQ Bypass Receives FDA “Breakthrough Device Designation” for the World’s First Fully Percutaneous Femoral-Popliteal Bypass Device
Designation Expedites Physician Access to Device for Patients with Extremely Long and Complex SFA Lesions MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug […]
Medtronic Evolut TAVR System Receives Updated U.S. Labeling Revising Precaution for Treatment of Low-Risk Patients with Bicuspid Aortic Stenosis
Revised Commercial Labeling Broadens Patient Population Who May be Candidates for Transcatheter Aortic Valve Replacement (TAVR) DUBLIN, Aug. 21, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Evolut™ TAVR platform […]
CHF Solutions’ Aquadex Products Granted Federal Supply Schedule Contract
EDEN PRAIRIE, Minn., Aug. 18, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to improving the lives of patients suffering from fluid overload, today announced that its Aquadex™ product line has been added to the Federal Supply Schedule, expanding access to all federal government agencies, […]
Endospan Receives FDA IDE Approval to Initiate a Pivotal Study of the NEXUS™ Aortic Arch Stent Graft System
HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS™ Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM). Earlier this year, FDA granted NEXUSTM designation as a […]
FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
TARRYTOWN, N.Y., Aug. 12, 2020 /PRNewswire/ — Homozygous familial hypercholesterolemia affects approximately 1,300 patients in the U.S., the vast majority of whom are unable to reach target LDL-C levels with currently available therapies Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a […]
Surmodics Receives FDA 510(k) Clearance for Sublime™ Radial Access 0.014 RX PTA Dilatation Catheter
Device designed to treat below-the-knee vessels from the radial arteries with industry’s longest (250 cm) working length EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance […]
New Rapid Cardiac MR Imaging Helps Detect and Manage Patient Heart Health During and After Cancer Treatments
United Imaging now preferred medical imaging partner for MyoStrain® and its unique diagnostic cardiac test. HOUSTON, Aug. 5, 2020 /PRNewswire/ — United Imaging, a global leader in advanced medical imaging and radiotherapy equipment, along with Myocardial Solutions, a medical technology company working to transform the cardiac and cancer care continuum, announced today […]
FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed (NASDAQ: ABMD). COVID-19 causes widespread inflammation which can […]
Biotricity Receives FDA clearance for Bioflux Software II System
The software significantly improves workflows for analysis, increasing efficiency and reducing costs REDWOOD CITY, Calif., Aug. 04, 2020 (GLOBE NEWSWIRE) — Biotricity Inc. (OTCQB: BTCY), a medical diagnostic and consumer healthcare technology company, today announced that it has received a 510(k) clearance from the FDA for its Bioflux Software II System. The software […]
Recent
Esperto Medical Awarded Grant by the Translational Research Institute for Space Health (TRISH) to Advance Noninvasive Monitoring Technology for Spaceflight
AQUAPASS REFORM-HF Pivotal Trial Meets Primary Endpoint, Demonstrating Significant Fluid Removal in Heart Failure Patients
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