Regulatory

Acutus Medical Announces FDA Clearance of Second-Generation AcQMap 3D Imaging & Mapping Catheter

Design Features Improve Handling and Deliverability to Enhance Efficiency CARLSBAD, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB) today announces FDA 510(k) clearance of the second-generation AcQMap® 3D imaging and mapping catheter which builds on its predecessor, improving handling and deliverability. This flagship 3D mapping and navigation catheter combines […]

US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack

– FDA Fast Track designation facilitates the development of potential new therapies that treat serious conditions and fulfill an unmet medical need – This Fast Track designation for empagliflozin emphasizes the urgent need for potential treatments that may improve outcomes following an acute myocardial infarction, more commonly known as a […]

Fitbit Receives Regulatory Clearance in Both the United States and Europe for ECG App to Identify Atrial Fibrillation (AFib)

With FDA 510(k) clearance and CE mark, the Fitbit ECG App may help prevent serious complications like stroke by allowing users to spot check for signs of AFib from their wrist SAN FRANCISCO–(BUSINESS WIRE)–Fitbit (NYSE:FIT) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking […]

Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study…

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 […]

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 […]

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 […]