News | Cardiovascular Business

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) announced the 2020 Experiential Learning Program site visit proposal solicitation period. The 2020 Fall ELP submission period is open from Monday July 8, 2019 – Thursday, August 8, 2019, at 12 p.m. EST. The ELP is intended to provide a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing and healthcare facilities to observe how medical devices are designed, developed and utilized.

Home July 17, 2019
Home
Technology | Heart Valve Technology

Abbott has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

Home July 17, 2019
Home
News | Congenital Heart

Elevated blood pressure and cholesterol levels in young adulthood may lead to an increased risk of heart disease later in life, regardless of later-in-life exposure to these risk factors, according to research published in the Journal of the American College of Cardiology.

Home July 16, 2019
Home
News | Radiopharmaceuticals and Tracers

NorthStar Medical Radioisotopes LLC announced completion of construction on its 20,000-square-foot molybdenum-99 (Mo-99) processing facility in Beloit, Wis., with equipment installation currently underway. Establishing this processing facility is part of NorthStar’s staged development and dual processing pathway approach to expanding current capacity and efficiencies in Mo-99 production.

Home July 16, 2019
Home
News | EP Mapping and Imaging Systems

Acutus Medical announced the publication of the UNCOVER AF study in Circulation: Arrhythmia and Electrophysiology. The study demonstrated 73 percent single-procedure freedom from atrial fibrillation (AF) at 12 months with the use of Acutus' AcQMap advanced cardiac imaging and mapping system. Acutus develops electrophysiology (EP) technology solutions built into an open platform EP suite of products that enable personalized and adaptive approaches to therapy.

Home July 15, 2019
Home
News | Balloon Catheter

Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during use, which may add time to the procedure and compromises the safety of the patient.

Home July 15, 2019
Home
Technology | Contrast Media

July 15, 2019 — The U.S. Food and Drug Administration (FDA) has approved Gadavist injection for use in cardiac magnetic ...

Home July 15, 2019
Home
News | Cardiovascular Surgery | Jeff Zagoudis, Associate Editor

Internet search engine giant Google unveiled a new Doodle on its homepage Friday, July 12, celebrating the life and work of cardiac surgeon Rene Favaloro. Favarolo, originally from Argentina, was one of the early pioneers of coronary artery bypass graft (CABG) surgery.

Home July 12, 2019
Home
News | CT Angiography (CTA)

Mednax Inc. and Mednax Radiology Solutions announced that Chief Medical Officer Ricardo C. Cury, M.D., FSCCT, will present at the 14th Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT), July 11-14 in Baltimore. His session is titled “Building a National Centers of Excellence in Coronary Computed Tomography Angiography (CCTA) to Support Implementation in Clinical Practice.”

Home July 11, 2019
Home
News | Computed Tomography (CT)

The Society of Cardiovascular Computed Tomography (SCCT) will present Stephan Achenbach, M.D., FSCCT with the inaugural 2019 Stephan Achenbach Pioneer Award in Cardiovascular CT at the SCCT 14th Annual Scientific Meeting (SCCT2019), July 11 –14 in Baltimore. The award recognizes individuals who have made landmark contributions by demonstrating a commitment to clinical excellence, research and education to the field of cardiovascular CT.

Home July 10, 2019
Home
News | Cardiovascular Clinical Studies

The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.”

Home July 10, 2019
Home
ASE 2019 virtual reality demonstration with TomTec which showed hot VR can be used to review complex 3-D anatomy and make more accurate measurements on cardiac imaging.
Feature | Cardiovascular Ultrasound | Dave Fornell, Editor

Here is an overview of the hot topics and new technology trends in cardiovascular ultrasound from the 2019 American ...

Home July 10, 2019
Home
Videos | Cardiovascular Ultrasound

This is an example of a cardiac echocardiography exam performed using an iPhone and the Butterfly IQ ultrasound ...

Home July 10, 2019
Home
360 Photos | Cardiovascular Ultrasound

This 360 degree photo shows a basic, point-of-care cardiac echocardiogram being performed using a smartphone turned into ...

Home July 10, 2019
Home
News | Stent Grafts

W. L. Gore & Associates Inc. (Gore) announced the first U.S. implant of the Gore Tag Conformable Thoracic Stent Graft with Active Control System. The successful procedure was performed by William Jordan, M.D., chief of the Division of Vascular Surgery and Bradley Leshnower, M.D., cardiothoracic surgeon, at the Emory University School of Medicine in Atlanta. This first case follows the recent U.S. Food and Drug Administration (FDA) approval for this new device.

Home July 10, 2019
Home
Subscribe Now