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.

FDA recalls infant incubators due to risk of door falling off

A loose screw on the Giraffe OmniBed is to blame. With updated use instructions and repairs, the incubators are safe to use.

MRI accident prompts questions on safety

CMS to make proposed MRI safety codes official

The new code family was created to "capture the physician work involving patients with implanted medical devices that require access to MR diagnostic procedures."

Rad's alleged involvement in peddling date rape drug lands him behind bars

Authorities became suspicious of the doctor after intercepting a package containing around 15 pounds of gamma-butyrolactone, a common date rape drug also known as “liquid ecstasy."

CMS updates outpatient reimbursement policy for Barostim device

CMS continues to show confidence in the benefits of baroreflex activation therapy with the Barostim device from CVRx.

‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Medicare money payment reimbursement dollar decline george washington

CMS makes 2025 Medicare cuts official—and doctors are not happy

CMS has published its final rule for the 2025 Medicare Physician Fee Schedule, and it includes significant payment cuts. Cardiology groups have been working hard to stop these changes from going into effect since they were first proposed in July.

Kentucky AG launches criminal probe after conscious man nearly has organs harvested

Three years ago Anthony Hoover was declared brain dead—until he woke up on the operating room table, moments before his organs were removed. His story has spurred a criminal investigation by Kentucky's attorney general.

Medicare issues final 2025 physician fee schedule with 2.83% conversion factor cut

“Despite rising practice costs, CMS continues to cut physician reimbursement, denying the reality of the burdens under which our healthcare system operates," SIR said Friday.

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