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.

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.
Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead
Dan Brillman, the former CEO and co-founder of coordinated care support service Unite Us, has left his position for a role in the Centers for Medicare & Medicaid Services, where he will be responsible for overseeing the federal government's safety net healthcare programs.

FDA announces recall of more than 250,000 interventional devices due to risk of catheter separation

The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far.

FDA approves Bayer’s imaging agent Ultravist for use in contrast-enhanced mammography

The Germany-based corporation said this is the “only contrast agent approved for this indication” in America.

American College of Radiology voices support for MD tapped to lead NIH amid confirmation hearing holdup

“We must not lose momentum," ACR, the Academy for Radiology & Biomedical Imaging Research and more than 100 other organizations wrote to leaders of the U.S. Senate.

The U.S. Food and Drug Administration (FDA) priority review, the FDA has cleared the Agepha Pharma USA LLC's drug Lodoco (colchicine) as the first anti-inflammatory atheroprotective cardiovascular treatment.

Cardiologists applaud FDA’s approval of colchicine for CVD

"The FDA's approval of colchicine confirms that we are entering a new era of patient care," said one veteran cardiologist familiar with the drug.

Physician-owned hospitals charge less for imaging than their counterparts

The finding comes as lobbying groups urge Congress to repeal an ongoing moratorium on doc hospital ownership

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

Moderna's updated COVID vaccine now awaits FDA authorization

"We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere,” Moderna's CEO said in the announcement.

American College of Radiology, AMA partner to fight nonphysician scope creep

ACR recently highlighted the collaboration, labeling scope of practice as “one of the leading issues that are addressed by state legislatures.”

artificial intelligence robot evaluates healthcare data

FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results

Anumana, Pfizer and Mayo Clinic all worked together to develop the advanced algorithm. The groups are now targeting full regulatory approval in the U.S., Europe and Japan.

Policy & Regulations

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

Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead