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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transthoracic echocardiogram images from 2024 ASE guidelines

American Society of Echocardiography shares updated expert recommendations on pediatric, neonatal echo

These new guidelines provide a fresh look at topics ASE has not addressed with official society recommendations in many years. 

FDA approves first transcatheter tricuspid valve replacement device, the EVOQUE system from Edwards Lifesciences

Edwards makes history, receives FDA approval for transcatheter tricuspid valve replacement device

The approval, based on positive results from the TRISCEND II trial, represents a significant milestone for the treatment of severe tricuspid regurgitation. 

CT-first strategy the most effective path forward when evaluating stable chest pain

Heart teams have several options when patients present with stable chest pain and require further testing. According to a brand new analysis of nearly 800 patients, CCTA may be the best place to start. 

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FDA announces Class I recall of more than 250,000 chest drains over safety concerns

According to the FDA, using these devices without following manufacturer recommendations could lead to “serious injuries or death." 

Farapulse Boston Scientific Pulsed Field Ablation PFA fda approval

FDA approves Boston Scientific’s pulsed field ablation system for AFib

The FDA’s final decision was based largely on positive results from the ADVENT clinical trial, which compared treatment with the Farapulse PFA System to the current standard of care.

Element Science Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

New patch-based wearable defibrillator receives CE mark approval

The device, which also received Great Britain’s UKCA marking, was specifically designed to be less bulky and easier to wear than other wearable cardioverter-defibrillators.

HeartFlow’s AI-powered CAD offering receives new CPT code with improved reimbursement rate

For this update to be finalized, the American Medical Association had to determine FFRCT Analysis met certain requirements in terms of its overall impact on patient care. John Farquhar, CEO of HeartFlow, described the news as "a win for everyone involved, most notably patients." 

Pi-Cardia ShortCut TAVR device

FDA grants new valve-in-valve TAVR offering its breakthrough device designation

The new device was designed to help clinicians perform valve-in-valve TAVR on certain high-risk patients. One cardiologist familiar with the technology said it could be easily added to any preexisting TAVR workflow. 

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Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

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

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