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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Medicare money payment physician

Hospital to pay $24.3M over TAVR allegations

According to a whistleblower, Cape Cod Hospital performed hundreds of TAVR procedures without following specific government requirements.

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

FDA clears advanced AI model for predicting heart failure risk

The new algorithm from Implicity evaluates implantable device data and monitors patients for changes that suggest they could experience severe heart failure symptoms in the near future. It was designed to alert clinicians up to weeks in advance.

cardiologist viewing heart data

Cardiologists examine how residual TR after transcatheter tricuspid valve repair impacts survival

Researchers tracked data from more than 600 patients, noting that heart teams may want to reconsider how they classify residual TR after treatment. 

Atraverse Medical Hotwire radiofrequency (RF) guidewire

Medical device startup gains FDA clearance for new RF guidewire, raises $12.5M

Atraverse Medical, a San Diego-based medical device company founded in 2022, designed the guidewire to give physicians as much freedom as possible while treating heart patients. 

4C Medical Technologies AltaValve

FDA grants breakthrough device designation to new TMVR device from 4C Medical

The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation. It is implanted via transseptal access and positioned above the native mitral valve.

FDA announces another new recall involving Abbott’s HeartMate 3 LVADs after 70 injuries, 2 deaths

Abbott issued the new recall after receiving more than 80 reports of blood or air entering the LVAD during implant procedures. Customers can still use these devices, but they are advised to follow specific steps to limit the risk of complications. 

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World Health Organization urges countries to limit salt intake to reduce risk of CVD, hypertension

The group wants countries to implement population-wide changes that can keep salt intake to a minimum. It estimates that such policies could save up to 900,000 lives in just a few years. 

Cardiology ranked No. 2 among all specialties with 122 FDA-cleared AI models

Only radiology is associated with more FDA-cleared AI algorithms than cardiology, according to new federal data. 

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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.