Regulatory

FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated in March 2019 as Class I Recall

DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]

Corvia Medical’s Interatrial Shunt Device (IASD®) Receives Breakthrough Device Designation For Heart Failure

TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD) for heart failure. The IASD is […]

Blood Flow Monitoring Device – FlowMet-R Gets FDA 510K Clearance

IRVINE, Calif., Oct. 2, 2019 /PRNewswire/ — Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its blood flow monitoring system, FlowMet-R, received its 510(k) clearance from the Food and Drug Administration (FDA). This clearance allows LAS to market and sell the FlowMet-R. The non-invasive portable device addresses a […]

FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers

MALVERN, Pa.–(BUSINESS WIRE)– The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT¹, an intelligent software assistant from Siemens Healthineers that brings artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant of the new AI-Rad Companion platform, AI-Rad Companion Chest CT […]

Abiomed Receives FDA PMA Approval for Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is: Minimally invasive, eliminating the need for a […]

U.S. FDA Clears Abbott’s High Sensitivity Troponin-I Blood Test That Aids Doctors in Diagnosing Heart Attacks Faster and More Accurately

Newly cleared diagnostic test could help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women ABBOTT PARK, Ill., Sept. 25, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced that its ARCHITECT STAT High Sensitivity Troponin-I blood test has received clearance from the U.S. Food and Drug Administration […]

Cardiovascular Systems, Inc. Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip

U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced […]

Medtronic Announces FDA Approval and U.S. Launch of Next-Generation Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients

Improved Functionality Across Four Valve Sizes and Lowest Delivery Profile on the Market, the Evolut PRO+ TAVR System Launches in U.S. as TAVR Patient Population Grows DUBLIN, Sept. 23, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration […]

LimFlow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption for the PROMISE II pivotal study of the LimFlow Percutaneous Deep […]

FDA Awards AnaBios Grant to Further Develop Preclinical Assay Using Human Primary Cardiomyocytes

SAN DIEGO, Sept. 17, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has named AnaBios the recipient of a grant to further develop its unique drug discovery platform utilizing muscle cells from the human heart (cardiomyocytes).  Funds from the grant will be used to develop a preclinical biomarker to identify the […]