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.

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.

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. 

American College of Cardiology (ACC) President Christopher Kramer, MD, FACC, spoke at a hearing of the U.S. House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies March 9 to urge lawmakers to allocate full funding for the Cardiomyopathy Health Education, Awareness, Research, and Training in Schools (HEARTS) Act (H.R.6829). It was signed into law in the closing weeks of the Biden administration. #ACC

ACC testifies in Washington to get funding for the HEARTS Act amid big cuts to healthcare

ACC President Christopher Kramer, MD, testified before a Congressional subcommittee to ask for federal funding to support a new law aimed at reducing sudden cardiac arrest deaths, and to support NIH research.

ACC President Cathie Biga, MSN, president/CEO Cardiovascular Management of Illinois, discusses a letter ACC sent to Health and Human Services Secretary Robert F. Kennedy Jr. stressing some of the big challenges facing healthcare and cardiology from Trump administration policies.

'We need to come together as a nation': Why science, not politics, should guide healthcare policies

ACC Immediate Past President Cathie Biga spoke to Cardiovascular Business about some of the challenges healthcare faces in the wake of mass layoffs and significant funding cuts put in place by the Trump administration.

FDA clears new device for enabling access to the heart’s surface without an exposed needle

CardioVia's ViaOne technology includes a blunt-tip needle that remains concealed to help interventional cardiologists and electrophysiologists treat cardiac arrhythmias with a reduced risk of perforation or any other complications. 

Around the web

Tom Price, MD, former secretary of Health and Human Services (HHS), said one way to address the growing shortage of physicians is to expand medical resident positions, but these are tied to Medicare spending so alternative means may be needed.

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.