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.

Nearly 600K bottles of blood pressure drug recalled due to carcinogen risk
The FDA has detailed three voluntary recalls for prazosin hydrochloride, a medication used to treat hypertension, due to safety concerns.
FDA clears new AI-enabled coronary plaque analysis software
Circle Cardiovascular Imaging, a Canadian medtech company, received the key approval for its cvi42 | Plaque platform.
Mammography services suspended at 2 hospitals following ACR review
A news release indicates the suspensions are due to breast images not meeting the college's clinical quality standards.
Consolidation may be driving radiologists away from practicing as generalists
Radiologists who experienced a practice closure are more likely to operate as subspecialists afterward, according to new Neiman research.
FDA warns Philips after issues arise at multiple manufacturing facilities
Meanwhile, the Amsterdam-based imaging giant said it has already taken action to begin correcting these issues.

Prominent radiology practice accused of refusing imaging services to wheelchair user

The dispute dates to August, when Suzanne Garraffa first contacted Connecticut-based Jefferson Radiology seeking X-rays.

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.

American College of Radiology asks CMS to permanently allow remote supervision of diagnostic tests

The Centers for Medicare & Medicaid Services started allowing this perk in 2020 amid the pandemic, but it is slated to go away by the end of 2024.

artificial intelligence regulation legislation

Physician congressman hopes to address ‘appalling’ inaction on Medicare pay fix by March

Rep. Larry Bucshon, MD, R-Ind, spoke during the American Medical Association’s National Advocacy Conference, which took place from Feb. 12-14 in Washington.

FDA announces recall of more than 50,000 infusion pumps

Smiths Medical says providers should double check that Medfusion Model 4000 pumps have had their software properly updated, after reports that earlier versions of the device software could cause harm.

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.

Outpatient imaging provider attempts to capitalize on closure of 2 local hospitals

Smart Scan Medical Imaging has sought to attract customers impacted by the news, noting the institutions were seeing 400 patients per month.

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.

Policy & Regulations

Nearly 600K bottles of blood pressure drug recalled due to carcinogen risk

FDA clears new AI-enabled coronary plaque analysis software

Mammography services suspended at 2 hospitals following ACR review

Consolidation may be driving radiologists away from practicing as generalists

FDA warns Philips after issues arise at multiple manufacturing facilities