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GE HealthCare Revolution Vibe CCTA

“FDA clearance comes at the perfect time, with guidelines being adopted clinically for cardiac CT and with positive reimbursement driving procedure growth," says Jean-Luc Procaccini, CEO, molecular imaging and CT.

The U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for the Globe Pulsed Field Ablation (PFA) System, and 510(k) clearance for both the Globe introducer sheath and the Globe Pulsed Field System mapping software from Kardium Inc. This add another competitor in the growing U.S. PFA market to treat atrial fibrillation (AFib).

It is the only integrated system that combines high-density mapping and PFA in a single device. The system uses a 122-electrode spherical array to enable rapid, single-shot pulmonary vein isolation, helping to streamline workflows.

Toby Rogers, MD, PhD, associate professor of medicine Georgetown University, and interventional cardiologist at MedStar Heart and Vascular Institute Structural Heart Disease program, explains how the transcatheter electrosurgical procedures for transcaval access, SESAME, LAMPOON and BASILICA has helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues.

Toby Rogers, MD, associate professor of medicine at Georgetown University and an interventional cardiologist at MedStar, explains how electrosurgical procedures for transcaval access have helped large numbers of patients receive transcatheter heart valves who otherwise would have been disqualified due to anatomical issues. 
 

the words "FDA recall" on a board

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August. 

Philips introduced a new cardiac monitoring telemetry platform designed to help address critical challenges in healthcare, including staff shortages and alarm management. A key component of the solution is the next-generation Telemetry Monitor 5500 is an integrated central monitoring unit solution that integrates the telemetry device platform.

Care teams can face alarm and cognitive overload, with an average of 350 alarms going off per patient per day. But Philips' new telemetry platform streamlines alarm management, delivers data-driven insights and automates clinical tasks—with operational simplicity and networking options.

Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, professor of pediatric cardiology, Northwestern University Feinberg School of Medicine, member of the American Society of Echocardiography (ASE) Board, and the chair of the ASE Pediatric and Congenital Heart Disease Council Steering Committee, explains how 3D echo is being used to better plan, guide and followup in congenital cardiac surgery.

Pei-Ni Jone, MD, FASE, director, echocardiography laboratory, Lurie Children’s Hospital Heart Center, member of the American Society of Echocardiography (ASE) Board, explains how 3D echo is being used to better plan, guide and follow up in congenital cardiac surgery.

Stereotaxis MAGIC SWEEP electrophysiology catheter

The Stereotaxis MAGiC Sweep gained FDA clearance in July and its first commercial use was announced this week.

Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years.

Jaime Warren, EdD, FACC, vice president of care transformation at MedAxiom, an ACC company, explains what is needed to address staffing shortages created by a 94% increase in cardiac CT volumes over the past 5 years. 

The analysis, published in the American Journal of Cardiology, focused on both the safety and effectiveness of these two treatment options. 

Drinking coffee also benefits patients who have not experienced a stroke or heart attack, though the impact is not as significant. 

The FDA categorized this as a Class I recall, which means it is an especially serious issue that can result in injury or death.  

Even with numerous vaccines now being distributed, the COVID-19 pandemic continues to cause havoc for health systems all over the world. 

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Anders Gilberg, senior vice president of government affairs at the Medical Group Management Association, explains why Congress needs to renew the Medicare geographic pay adjustments in rural areas—to make payments competitive with urban areas and help retain physicians in those communities.

GE Healthcare reports Q2 revenue growth of 3% and lower than expected tariff losses at $550 million.

Hospitals are awarded Honor Roll points if they rank in one or more of the 15 specialties that U.S. News evaluates, and in one or more of the 22 procedures or conditions for patient outcomes.