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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Noteworthy FDA approvals of the week: Ceiling-mounted CT angiography, AI for brain-adjacent bleeds

Two companies serving medical imagers just had products cleared for marketing in the U.S.

Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA

Regulatory Roundup: FDA clears AI-powered Apple Watch competitor, grants breakthrough designation to new heart failure device

Ancora Heart received the FDA’s breakthrough device designation for its AccuCinch Ventricular Restoration System, a new minimally invasive transcatheter device designed for the treatment of heart failure.

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Cardiologists applaud new research on social/structural determinants of health among heart patients

The American Heart Association and Association of Black Cardiologists announced the winners of a six-month data challenge, describing health equity as "one of the most pressing areas in healthcare.”

Proposed Medicare Physician Free Schedule would decrease cardiology payments, ACC calls it ‘the continuation of a troubling trend’

CMS also announced that the penalty phase of its Appropriate Use Criteria Program has been delayed yet again.

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Could an effective breast cancer therapy be bad for the heart? NIH awards $3.1M to find out

Researchers will examine stress test results, CT images, and blood tests for women who undergo estrogen depletion as a treatment for breast cancer.

American Society of Echocardiography (ASE) past president Jonathan Lindner, MD, FASE, is a newly named advisor to the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), which advises the Centers for Medicare and Medicaid Services (CMS) on whether services and supplies are reasonable and necessary under Medicare.

Cardiologist Jonathan Lindner to advise influential Medicare committee

As a MEDCAC advisor, American Society of Echocardiography past president Jonathan Lindner, MD, will help decide whether services and supplies are reasonable and necessary under Medicare.

The most successful case to date of a pig organ being transplanted into a human occurred back in January, when specialists at the University of Maryland Medical Center (UMMC) in Baltimore transplanted a modified pig heart into 57-year-old David Bennett. The FDA approved the heart transplant transplant through an emergency authorization typically reserved for experimental procedures seen as a patient’s last chance at survival. Bennett did die of heart failure two months later, but UMMC specialists had been “

FDA may allow clinical trials of pig organ transplants into human patients

The FDA would approve trials on a case-by-case basis, according to an anonymous source close to the situation. 

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Judge says Apple violated ECG patents, making U.S. import ban of Apple Watches a possibility

A judge from the U.S. International Trade Commission has said Apple violated multiple AliveCor patents. This story, however, is far from over.

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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.