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.

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.
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.
FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus
The company is working to commercialize MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
Medicare now covers renal denervation for patients with uncontrolled hypertension
This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.

UnitedHealthcare in dispute with maternity practice over $1M in claims

Axia Women’s Health has accused the insurer of failing to honor continuity of care agreements for 2,100 patients, while questions remain over fair pricing and appropriate care delivery.

artificial intelligence regulation legislation

Lawmakers propose bipartisan bill to undo physician Medicare pay cut

Led by Greg Murphy, MD, House representatives are pushing the Medicare Patient Access and Practice Stabilization Act.

money gavel court lawsuit legal judge judgement

Judge grants class-action status in suit over controversial $164M radiology practice sale

The dispute dates to December 2017 when Colorado Springs-based Envision Radiology became 100% owned by its employees.

FDA greenlights first non-opioid treatment for severe pain in 20 years

Journavax was shown in clinical trials to be safe and effective, with no addictive potential.

Nina Kottler, MD, Radiology Partners, offers overview of the U.S. AI regulatory landscape as government and radiologists work on ways to ensure artificial intelligence is not bias and works properly.

Overview of the regulatory landscape of AI in radiology

Nina Kottler, MD, associate CMO for clinical AI at Radiology Partners, explains the movement toward greater regulation of artificial intelligence and the need to test for bias.

congress money legislation lawmaker bill senate house senator representative

Cardiologist-supported bill to stop ‘harmful’ Medicare cuts returns to Congress

A bipartisan bill designed to block recent Medicare payment cuts has been reintroduced to Congress after failing to pass in 2024. Will things be any different this time around?

Swedish total artificial heart tech granted FDA’s humanitarian use designation

Realheart celebrated the news, noting that multiple preclinical trials focused on the technology's safety and effectiveness are currently underway.

Industry Watcher’s Digest

Last week’s blastoff of the Chinese AI company DeepSeek struck many like a cold bucket of water in the face.

Policy & Regulations

FDA clears new AI-enabled coronary plaque analysis software

Consolidation may be driving radiologists away from practicing as generalists

FDA warns Philips after issues arise at multiple manufacturing facilities

FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus

Medicare now covers renal denervation for patients with uncontrolled hypertension