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 […]
Tag: FDA
Tinton Falls Company Gets FDA Approval For Early Heart Attack Detection Device
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 […]
Medtronic Announces Renal Denervation Pivotal Trial for the Treatment of Hypertension
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 […]
Fischer Medical Receives U.S. FDA 510(k) Clearance to Market Bloom2 Cardiac Stimulator
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 […]
Neurovascular Embolization Coils: Healthcare Provider Letter – Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up
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 […]
FDA Approves the World’s Smallest Mechanical Heart Valve for Pediatric Patients with Heart Defects
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 […]
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world
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 […]
FDA Permits Marketing of Clinical Decision Support Software for Alerting Providers of a Potential Stroke in Patients
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 […]
FDA adds safety alert for Zoll LifeVest
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 […]
MEDTRONIC RECEIVES FDA CLEARANCE FOR RIPTIDE(TM) ASPIRATION SYSTEM
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 […]
