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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Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Watchman FLX Pro left atrial appendage closure (LAAC) device

Boston Scientific gains FDA approval for Watchman FLX Pro LAAC device

This represents the latest iteration of the Watchman technology, which was first approved by the FDA back in 2020. 

FDA shares update on heart devices linked to multiple recalls and patient deaths

The devices, designed to provide temporary support to a patient's left ventricle, have been associated with a long list of issues in recent months. 

healthcare value value-based care money dollar

First 10 drugs chosen by White House for Medicare price negotiations include blood thinners, heart failure meds

Medicare enrollees paid a total of $3.4 billion in out-of-pocket costs for these drugs in 2022 alone, according to new data shared by the White House. 

Withings Body Scan Connected Health Station FDA cleared

FDA clears new smart scale capable of detecting AFib, other cardiovascular issues

The Body Scan Connected Health Station includes a high-strength glass platform with four weight sensors and 14 ITO electrodes and a retractable handle with four stainless steel electrodes.

Deferred testing for low-risk chest pain patients is safe, limits unnecessary catheterizations

Once physicians confirm a patient's CAD risk is low, they can feel comfortable putting diagnostic testing on hold. 

The Medtronic Symplicity Spyral Renal Denervation system uses a catheter that curls in the renal artery to place radiofrequency electrodes against the vessel wall to ablate the nerves that control vasodilation, so the artery can be propped in the fully open position.

FDA panel votes not to endorse Medtronic renal denervation system

The vote was close, initially ending with a tie, but the panel ultimately decided there were too many questions related to the device's long-term benefits for patients with uncontrolled hypertension.

Recor Medical's Paradise Ultrasound Renal Denervation System

FDA panel votes in favor of Recor Medical renal denervation system

A few members of the panel did question the device's efficacy and long-term durability. The FDA will now use these findings to make its final decision related to the system's approval. 

Video of ASE lobbyists explaining issues with Medicare funding policy reform in Washington DC.

Key government policies impacting cardiac ultrasound

Two experienced lobbyists who represent the American Society of Echocardiography detailed some of the biggest issues they are working on in Washington.

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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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