The Latest Cardiac and Vascular News
DENVER, April 9, 2018 /PRNewswire/ — Fischer Medical has announced that the Bloom2 cardiac electrophysiology stimulator device has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Bloom2stimulator is a fundamental component of nearly all electrophysiology (EP) procedures to diagnose and treat cardiac rhythm disorders. The release of the digital version of […]
ISSUE: The FDA is providing information about the potential for increased image artifact associated with Magnetic Resonance Angiography (MRA) imaging for patient follow-up of certain post neurovascular embolization coil procedures. Neurovascular embolization coils are used in the treatment of brain aneurysms and other vascular abnormalities. These coils are prescription devices […]
ABBOTT PARK, Ill., March 6, 2018 /PRNewswire/ — Abbott today announced the U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until […]
SILVER SPRING, Md., March 6, 2018 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with […]
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 […]
