The Latest Cardiac and Vascular News
Stratford-upon-Avon, UK, 08 June 2018 – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell […]
DUBLIN – June 1, 2018 – The United States Food and Drug Administration (FDA) has classified Medtronic plc’s (NYSE: MDT) recent voluntary urgent field action related to the HeartWare(TM) HVAD(TM) System unexpected power source switching as a Class I recall. Class […]
Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced the completion of a $2.8 million Series C funding round. The financing follows the company’s recent De Novo application […]
Menlo Park, Calif. – May 1, 2018 – iSchemaView, the leader in cerebrovascular imaging analysis, today announced it has received final clearance from the U.S. Food and Drug Administration (FDA) for RAPID CTA, the company’s 3D imaging solution for Computed Tomography […]
TORONTO–(BUSINESS WIRE)– Conavi TM Medical Inc. (www.conavi.com) is pleased to announce that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NovasightTM Hybrid System. The system enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) […]
Angel Medical Systems, Inc. of Tinton Falls announced that they have received FDA pre-market approval on a medical device that detects heart attacks before patients experience symptoms. The AngelMed Guardian System is an implantable heart monitor with internal and external […]
DUBLIN – April 9, 2018 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin an investigational device exemption (IDE) pivotal trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood […]
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 […]
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 […]
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 […]
