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.

12 charged in Florida as part of ‘Operation Nightingale’ sting on low-quality nursing schools

The defendants include operators and staff at nursing schools that were shut down over accusations they provided pay-for-play degrees that RNs and LPNs used to obtain licenses.

Dana Smetherman, MD, MPH, MBA, FACR, chief executive officer of the American College of Radiology, explains how the consolidation of radiology practices into larger corporate entities now makes up more than 50% of how radiologists are employed. This led to changes in how ACR accredits sites.

ACR changing its accreditation process in response to corporate consolidation

CEO Dana Smetherman, MD, MPH, MBA, explains how the consolidation of radiology practices has shifted how the college thinks about its processes.

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.

Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.

Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants

The finding is based on an analysis of nearly 1.4 million office-based imaging claims, conducted by the Harvey L. Neiman Health Policy Institute.

prior authorization claim deny denial insurance insurer payer Medicare Advantage

Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services

“It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” says Rep. Mark Pocan, D-Wis.

Referrers frequently failing to recommend patients for key interventional radiology procedure

An analysis of nearly 272,000 uterine fibroid healthcare encounters shows that only about 4% of women underwent uterine fibroid embolization, a minimally invasive IR treatment option.

WSJ: UnitedHealth seeks meeting with Trump as part of lobbying effort

The Wall Street Journal said that President Donald Trump has yet to meet with company representatives. However, UnitedHealth CEO Stephen Hemsley reportedly met with members of the administration in Washington.

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