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 announces new Class I recalls due to safety issue with Medtronic catheters

More than 100,000 surgical devices are included in these recalls, and there may be "limited product availability" in the months ahead. The FDA first warned the public about this issue in August.

Kneecapping National Institutes of Health will stifle economic growth, radiology groups warn

Over 500 healthcare organizations including the ACR issued their plea as Congress considers 2026 funding for the key federal agency.

HHS restoring deleted health information following legal challenge

A trove of content and data studies was purged from federal websites in an effort to eliminate “diversity, equity and inclusion.” That sweep also removed facts on maternal health, opioid addiction and more, leading to multiple lawsuits. One has now been settled.

Report: HHS suppresses major study that found link between alcohol and cancer

Speaking to Vox, the authors said they were informed the results of their major study commissioned by the Department of Health and Human Services (HHS) would not be published. However, there appeared to be nothing wrong with the methodology of the analysis.

New partnership seeks to increase imaging departments' remote-scanning capabilities

Many organizations are interested in remote scanning as a means of addressing ongoing technologist staffing shortages.

HHS announces crackdown on providers failing to share radiology results, other info

Secretary Robert F. Kennedy Jr. has directed the agency to increase resources dedicated to curbing the “harmful practice of information blocking.”

Over 1,000 HHS employees ask Congress, Trump to depose RFK

A group called Save HHS has sent an open letter to HHS Secretary Robert F. Kennedy Jr., demanding his resignation. If he refuses, the undersigned have asked Trump and Congress to remove Kennedy from power.

Florida looks to end all vaccine mandates, including those deemed routine

In a press conference held by Gov. Ron DeSantis, Florida Surgeon General Joseph Ladapo, MD, PhD, condemned all compulsory vaccinations, declaring that the “body is a gift from God.”

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