The Latest Cardiac and Vascular News
SILVER SPRING, Md., Feb. 13, 2018 /PRNewswire-USNewswire/ — Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. A stroke is […]
Patient death prompts safety warning by FDA. Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure by FDA.gov ISSUE: FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to […]
DUBLIN – January 16, 2018 – Medtronic plc (NYSE:MDT) today announced that the company’s Neurovascular business unit received U.S. Food and Drug Administration (FDA) clearance of the Riptide(TM) Aspiration System, adding a valuable tool to the Acute Ischemic Stroke (AIS) product portfolio. The Riptide Aspiration System is designed to retrieve thrombus […]
MONMOUTH JUNCTION, N.J., Dec. 21, 2017 /PRNewswire/ — CytoSorbents (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its flagship CytoSorb® blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the U.S. Food and Drug Administration (FDA) has granted approval of its REFRESH 2 Investigational Device Exemption […]
Gottlieb updates on Puerto Rico med device manufacturing recovery OCTOBER 20, 2017 BY SARAH FAULKNER In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has been working with federal and local agencies, today provided an […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a confirmatory clinical study to evaluate the safety and effectiveness of the Nellix […]
Endovascular Graft Systems: Letter to Health Care Providers – Type III Endoleaks Associated with Use [Posted 09/28/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Radiology ISSUE: The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular […]
DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]
Looks like the FDA will be increasing the user fees for fiscal 2018 Most FDA user fees set to rise 33% AUGUST 30, 2017 BY BRAD PERRIELLO, MassDevice The latest user fee authorization enacted last week has most of the fees medical device makers pay the FDA to review its products rising […]
Cook said to be recalling this device because of blood clots that can form within the graft after implantation. Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall – Potential Formation of Thrombus Inside Device AUDIENCE: Risk Manager, Cardiology, Surgery, Patient ISSUE: Cook Medical Inc. is recalling the […]
