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. 

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Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Evolut FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

FDA approves Medtronic’s next-generation TAVR system with new frame design

The Evolut FX+ TAVR system includes an updated diamond-shaped frame, which was made four times larger than previous models to offer improved coronary access. It was also designed to provide more space for operators to guide and maneuver the catheter during procedures.

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Imaging’s total share of US healthcare spending plummets as others record gains

The percentage of patients who received imaging services also declined from 46% in 2010 down to 40% by 2021, experts wrote in Health Affairs Scholar. 

FDA approves new drugs for pulmonary arterial hypertension from Johnson & Johnson, Merck

Cardiologists now have two more tools to help them combat PAH, a rare vascular condition that often leads to heart failure.

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Radiology the only category to see year-over-year decrease in insurers’ max allowed amount

Transparency firm Fair Health recently analyzed data around this key figure, which represents the highest amount a plan will pay for a covered service. 

Newsweek ranked the 50 best heart hospitals in the world

Hospital accused of implanting experimental heart valve in young patient without proper consent

Members of Congress are now asking the FDA to investigate a parent's claim that her 14-year-old son was treated with an experimental heart valve without proper consent. The valve eventually failed and had to be replaced. The hospital has said its heart team did nothing wrong. 

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CNN highlights potential ‘seismic shift’ for FDA dual mandate due to Supreme Court abortion case

An expansion in access to mifepristone for telehealth patients is at risk before the Supreme Court. What does this mean for the FDA approvals process?

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Radiologists voice support for lawsuit against Biden administration

The American College of Radiology, American College of Emergency Physicians and American Society of Anesthesiologists want a court of appeals to uphold a recent ruling. 

Biosense Webster gained CE mark approval for its Varipulse pulsed field ablation (PFA) system in Europe

Biosense Webster takes key step toward FDA approval for Varipulse PFA system

The company already received CE mark approval for its new PFA offering and hopes it will soon be approved for sale in the United States.

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