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 […]
Coronary/Structural Heart
HeartFlow Announces Collaborative Research Agreement with Imperial College London
REDWOOD CITY, Calif.–(BUSINESS WIRE)– HeartFlow, Inc. today announced that it has entered into a collaborative research agreement with Imperial College London. The collaboration will enable experts from HeartFlow and Imperial to work side-by-side on joint projects in the areas of medical imaging and deep learning. The company’s non-invasive HeartFlow® FFRct Analysis leverages deep […]
Philips introduces next generation of IntelliSpace Cardiovascular informatics platform at HIMSS 2018
Comprehensive informatics and imaging solution features enhanced security protocols to meet industry-leading standards Improved interoperability and standardization increases scalability across the hospital enterprise to help improve efficiency and quality AMSTERDAM and LAS VEGAS, March 5, 2018 /PRNewswire/ — Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of IntelliSpace Cardiovascular 3.1, […]
Corindus Receives FDA Clearance for First Automated Robotic Movement in technIQ™ Series for CorPath GRX Platform
WALTHAM, Mass.–(BUSINESS WIRE)– Corindus Vascular Robotics Inc. (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the first automated robotic movement designed for the CorPath GRX platform. The proprietary software feature, named “Rotate on Retract” […]
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon. OrbusNeich’s […]
4C Medical’s Novel Mitral Regurgitation Therapy to be Highlighted at CRT 2018 Meeting
BROOKLYN PARK, Minn., March 1, 2018 /PRNewswire/ — 4C Medical Technologies, Inc. (4C Medical), a developer of minimally invasive technologies for structural heart disease, today announced that its medical device for mitral regurgitation (MR) will be highlighted in two presentations at the Cardiovascular Research Technologies (CRT) meeting held March 3-6, 2018 in Washington, DC. 4C Medical […]
Scandinavian Real Heart Selects AdaCore Embedded Software Development Platform for Revolutionary Artificial Heart
NEW YORK & PARIS & NUREMBERG, Germany–(BUSINESS WIRE)–Embedded World–AdaCore, a trusted provider of software development and verification tools with headquarters in New York and Paris, today announced that Scandinavian Real Heart AB in Sweden is using a suite of AdaCore software solutions to develop reliable embedded software for its revolutionary Total Artificial […]
REVA ANNOUNCES CE MARK AND FIRST IMPLANT OF THE FANTOM ENCORE BIORESORBABLE SCAFFOLD
2.5 millimeter Diameter Size with Market-Leading 95 micron Strut Profile Secures Early Approval San Diego, California (Monday, February 26, 2018 – PST) – REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, announces CE Mark of the 2.5 millimeter diameter size […]
Medtronic Launches First 2.0 mm Drug-Eluting Stent in United States Designed to Treat Patients with Small Vessels
FDA Approved, Resolute Onyx 2.0 mm DES Technology Tackles Clinical Challenge of Treating Coronary Artery Disease in Previously Untreatable Patients DUBLIN – February 26, 2018 – Designed specifically for small vessels, Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute […]
NaviGate Cardiac Structures Inc. (“NCSI”) reports GATE™ bioprosthesis as the first transcatheter valve replacement in Canada to treat tricuspid regurgitation
LAKE FOREST, Calif.–(BUSINESS WIRE)–NaviGate Cardiac Structures Inc. (“NCSI”) announced today that on 2 Feb. 2018, its catheter-guided GATE™ valved-stent bioprosthesis beame the first Canadian orthotopic valve replacement to treat severe tricuspid regurgitation. The procedure was performed at the Quebec Heart and Lung Institute, Laval University (Quebec City, Canada) by the Institute’s […]



