DUBLIN – September 11, 2018 – Today, Medtronic issued the following statement confirming it has received FDA warning letters (CMS #560736 and #562437) related to its Cardiac Rhythm and Heart Failure facilities located in Mounds View, Minn., and in Juncos, Puerto […]
Regulatory
With Latest FDA 510(k), physIQ Achieves Another Clearance as a Pioneer in AI Analytics
CHICAGO–(BUSINESS WIRE)–PhysIQ, a leader in applying AI analytics to biosensor data, today announced it has received FDA 510(k) clearance for its Atrial Fibrillation (AFib) detection analytics engine. The clearance extends physIQ’s portfolio of FDA 510(k) cleared analytics designed to generate clinical […]
FDA Designates AliveCor’s Bloodless Hyperkalemia Test a “Breakthrough Device”
MOUNTAIN VIEW, Calif., Sept. 10, 201 /PRNewswire/ — AliveCor, recently recognized as the Most Innovative Company in Artificial Intelligence, today announced that the U.S. Food and Drug Administration has given the company’s KardiaK Software Platform the rarely granted designation of “Breakthrough Device.” […]
Cook Medical Announces Successful Resolution of 2014 FDA Warning Letter
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical today announced that it received a close-out letter from the U.S. Food and Drug Administration resolving a 2014 warning letter for processes related to the quality system at the company’s manufacturing facility in Bloomington, Indiana. The […]
Avinger Announces 510(k) Filing of Pantheris Small Vessel Device
REDWOOD CITY, Calif., Aug. 30, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) […]
CathWorks FFRangio™ System Files FDA 510(k) Submission
KFAR-SABA, Israel–(BUSINESS WIRE)–CathWorks announced that it has submitted its CathWorks FFRangio™ System to the United States Food & Drug Administration (FDA) for review and 510(k) market clearance. The CathWorks FFRangio System is the non-invasive FFR platform that quickly and precisely delivers objective […]
GORE® Molding & Occlusion Balloon for Endovascular Aortic Repair Receives Approval in the United States, Japan, and Europe
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) announced FDA 510(k) clearance, approval from the Japanese Ministry of Health, Labour, and Welfare, and receipt of CE Mark for the innovative GORE® Molding & Occlusion Balloon, a compliant polyurethane balloon catheter designed […]
BioSig Technologies Announces FDA 510(k) Clearance for PURE EP System
Santa Monica, CA, Aug. 14, 2018 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (OTCQB: BSGM), announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA). The non-invasive PURE EP System is […]
Medicure Announces FDA Approval of Acute Care Cardiovascular Drug Sodium Nitroprusside Injection
WINNIPEG, Aug. 13, 2018 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce that the United States Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Sodium Nitroprusside […]
JenaValve Technology Initiates U.S. Patient Enrollment in Early Feasibility Study of Next-Generation TAVR System for the Treatment of Severe Aortic Stenosis and Severe Aortic Regurgitation
IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment in the Early Feasibility Study (EFS) of its next generation JenaValve Pericardial TAVR System using the Everdur™ […]
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