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.

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.
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.
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 opts not 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.

American College of Radiology initiative seeks to improve transparency among AI vendors

The ACR Data Science Institute’s “AI Central” allows physicians to select algorithms that have been vetted for performance.

FDA clears AI-powered brain MRI software from French firm Pixyl

The product aims to reduce radiologists’ read times while bolstering the detection of certain neurological disorders.

Arineta Cardio Imaging cardiovascular CT scanners AI

FDA clears AI-powered image reconstruction technology for cardiac CT scanners

The new technology, trained using more than 3 billion data points, was designed to reduce image noise and improve the overall quality of CT scans.

Medtronic Symplicity Spyral renal denervation

FDA approves another renal denervation system for hypertension

This is the second time in a matter of weeks the FDA has approved an RDN system for uncontrolled hypertension. The SCAI issued a statement about this trend, calling it a “game-changer for both interventional cardiology and the treatment of hypertension."

CVD deaths have increased dramatically, undoing years of progress

The COVID-19 pandemic undid years and years of progress in terms of preventing CVD-related deaths. What can be done to help reverse this trend once and for all?

No Surprises Act purportedly pushing providers in radiology and other specialties ‘to the brink’

The law triggered some of the year’s biggest bankruptcies, with investors eyeing similar debt-laden provider groups that could be vulnerable.

FDA announces recall of more than 32 million disposable syringes

The new-look syringes are causing significant issues when used with syringe infusion pumps. This is a Class I recall, which means the FDA believes the products “may cause serious injuries or death.”

Cardiologist reprimanded for performing surgery after testing positive for COVID-19

He has agreed to pay an administrative fee of $1,100 within the next three months.

Policy & Regulations

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

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

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

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

Medicare opts not to make CT radiation-related quality measure mandatory in 2027