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. 

AI artificial intelligence stethoscope doctor

FDA grants AI software for imaging-based heart assessments its breakthrough device designation

The new software was also added to the FDA's Tap Pilot program, an honor reserved for “high-quality, safe, effective and innovative medical devices."

March 5, 2024
Kate Hanneman, MD, University Of Toronto, explains why vendors and hospitals are increasingly discussing lowing their carbon footprint by starting with radiology. 

What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

March 1, 2024
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent Drug-Coated Balloon (DCB) for the treatment of coronary in-stent restenosis (ISR) in patients with coronary artery disease.

FDA approves Boston Scientific’s new drug-coated balloon for coronary in-stent restenosis

Interventional cardiologists have been anticipating this news for quite some time. The device, the first of its kind, provides an alternative treatment option to repeat PCI or cardiac surgery for patients with coronary ISR.

March 1, 2024
Biosense Webster gained CE mark approval for its Varipulse pulsed field ablation (PFA) system in Europe

Biosense Webster gains CE mark approval for new PFA system

The news represents yet another big regulatory approval for PFA technology in 2024. Could FDA approval be next for Biosense Webster?

February 29, 2024
The U.S. Food and Drug Administration (FDA) has issued a new warning against the use of watches, rings and other devices that claim to measure blood glucose levels without piercing the skin. These unapproved devices come from “dozens of companies” and are sold “under multiple brand names.”

FDA warns against use of unauthorized smartwatch, smart ring devices to measure blood glucose levels

Any devices that claim to make blood glucose measurements without piercing the user's skin are associated with a heightened risk of error, the agency said. 

February 22, 2024
Video of Patricia Keegan, NP, Emory, explains value of the ACC TVT NCDR registry for TAVR and why it is important from both a quality monitoring standpoint and for attracting patients to your program.

Data registries have been a huge success for U.S. structural heart programs

ACC/STS National Cardiovascular Data Registry metrics reporting for TAVR is important for marketing and care quality, explains Patricia Keegan, NP, with the Emory Heart and Vascular Center.

February 16, 2024
doctor looking at CLTI patient's leg

FDA grants bioresorbable scaffold system its breakthrough device designation to treat infrapopliteal lesions

The new drug-eluting device was designed to provide both stability and flexibility to patients presenting with below-the-knee lesions.  

February 14, 2024
An FDA panel will discuss its recommendations related to Abbott's TriClip G4 transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation.

FDA advisory panel votes in favor of Abbott’s TriClip device for tricuspid regurgitation

After hours of discussion, the panel determined that the benefits of using the TriClip G4 TEER system to treat TR outweigh any potential risks. 

February 14, 2024

Around the web

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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