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.

U.S. News & World Report children’s hospitals cardiology heart surgery

Study unearths high rates of incidental findings on pediatric CT scans for trauma

About 10% of these cases required immediate or urgent action, researchers detailed in Clinical Imaging.

FDA aiming to modernize 510(k) process that many radiology devices must go through

The administration also is accepting comments on the draft guidelines and plans to host a webinar on Oct. 26.

Medtronic faces lawsuit for sharing data of customers who used the InPen smartphone app

Medtronic faces class-action lawsuit after patient data shared with Google, other third-party sites

The complaint describes Medtronic's actions as “immoral, unethical, oppressive and unscrupulous.”

Imaging advocacy group hopes to counteract ‘dangerous care delays and denials’ in PET payment

The American Society of Nuclear Cardiology is pushing payers to more consistently and correctly cover medically necessary scans without prior authorization.

CMS kick-starts key piece of IDR process under surprise billing law

The federal agency first announced the move Tuesday, noting that it pertains to single and bundled payment disputes submitted on or before Aug. 3.

House leaders reveal ‘major’ healthcare bill that includes radiologist-opposed Imaging Services Price Transparency Act

The rule would establish a list of “at least 50” shoppable radiology exams for which providers must publicly disclose pricing on their websites.

Philips will pay $479M to settle class-action lawsuit stemming from product recall

The Amsterdam-based imaging industry giant emphasized that the agreement “does not include or constitute any admission of liability, wrongdoing or fault.”

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Watchman FLX Pro left atrial appendage closure (LAAC) device

Boston Scientific gains FDA approval for Watchman FLX Pro LAAC device

This represents the latest iteration of the Watchman technology, which was first approved by the FDA back in 2020.

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