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.

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August.

AI for opportunistic osteoporosis screening inks FDA clearance

The tool analyzes routine hip and pelvis X-rays for signs of low bone mineral density.

Radiology groups voice ‘enthusiastic support’ for proposal to add 14,000 more Medicare-funded residency slots

The Society of Interventional Radiology and American College of Radiology are thanking lawmakers for reintroducing the Resident Physician Shortage Reduction Act.

The Dexcom G7 Continuous Glucose Monitoring System

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.

COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology

Why all heart patients should be vaccinated against the flu, COVID-19, RSV

The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated.

artificial intelligence money robot dollar AI

Medicare has denied $16M worth of radiology artificial intelligence claims

The federal payment program first started paying for AI in 2018 and has denied about 53% of claims (or 53,857) submitted by radiologists since then, experts detail in JACR.

Members of Congress propose tapping foreign-born physicians to relieve radiology workforce shortages

Lawmakers in both chambers have reintroduced the Healthcare Workforce Resilience Act, touting support from the American Hospital Association and several physician societies.

Medicare proposal eliminates plan to make CT radiation-related quality measure mandatory in 2027

The measure evaluates the proportion of scans that exceed certain thresholds for image noise or radiation dose across 18 categories.

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