Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

LUMA Vision Verafeye Visualization Platform

FDA clears catheter-based 4D visualization platform for complex heart procedures

The new technology from LUMA Vision allows operators to deliver 2D and 4D ultrasound images in real time. The advanced catheter was built with maneuverability and increased visibility in mind.

Video of Erik Rockswold explaining the administrative burdens of the MIPS program.

Radiology groups face hardships under the Medicare MIPS program

Erik Rockswold, director research and quality, Rayus Radiology, explains the administrative burdens radiology groups experience for little return from the Merit-Based Incentive Payment System.  

Trump orders changes to Medicare drug price negotiations

President Donald Trump has directed the Department of Health and Human Services to work with Congress on changes to Medicare drug price negotiations, with the stated goal of further lowering prescription costs.

WiSE CRT system EBR Systems leadless pacing

FDA approves leadless CRT device for heart failure

The WiSE CRT system is approximately the size of a single cooked grain of rice. It works with a patient’s existing implant to provide biventricular pacing. 

HeartFocus DESKi

FDA clears AI-powered echocardiography software

HeartFocus guides users through the entire process, making it so that even novices can deliver high-quality echocardiograms every time.

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American College of Radiology criticizes prominent study claiming CT imaging causes cancer

“These estimates put CT scanning on par with other well-known risk factors for cancer, including alcohol and obesity," experts write in JAMA Internal Medicine

Edwards Lifesciences Sapien M3

Edwards Lifesciences announces key approval for new mitral valve replacement system

The Sapien M3 device was designed to treat symptomatic mitral regurgitation in patients who are not suitable candidates for surgery or transcatheter edge-to-edge repair.

SCAI President James B. Hermiller, Jr., MD, director of the transcatheter structural heart program at Ascension St. Vincent Heart Center, Indianapolis, outlined the organization’s key policy priorities for the year. Among them: physician payment reform, peer review overhaul, medical education debt relief, the elimination of non-compete clauses, and physician mental health protections.

Reimbursements, non-compete clauses and more: SCAI focused on key policies in interventional cardiology

SCAI President James B. Hermiller, Jr., MD, detailed the group's key policy concerns in 2025 and beyond in a new video interview.