The Latest Cardiac and Vascular News
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 I recalls describe situations where there is reasonable risk of […]
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 to the U.S. Food and Drug Administration (FDA) for the Early Bird™ […]
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 Angiography. RAPID CTA is the newest addition to iSchemaView’s industry […]
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) and Optical Coherence Tomography (OCT). IVUS or OCT are typically […]
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 alerting capabilities to urge at-risk patients with pre-existing cardiac conditions […]
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 pressure (hypertension). Renal denervation is a minimally invasive procedure intended […]
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 […]
