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.

How a newly secured 3D printing patent could stabilize radioisotope production

Recently, a patent for 3D printed uranium targets was secured by the National Center for Nuclear Research (NCBJ) in Swierk, Poland, and it could increase the production of Molybdenum-99 (Mo-99) globally.

Virtual reading room remains popular post-pandemic among certain radiologists, referrers

A large academic medical center launched a virtual radiology reading room in 2020 to comply with COVID-related social distancing guidelines. Today the room is still something of a hit.

FDA changes indications for Impella RP heart pump after dramatic shift in mortality rate

The Impella RP System is still associated with significant benefits, the FDA said, but there are certain high-risk patients who should no longer be eligible for treatment.

Integra LifeSciences to acquire SIA in deal worth up to $140M

Integra LifeSciences Holding Corporation, a global medical technology company, has agreed to acquire Surgical Innovation Associates (SIA), which is known as the manufacturer of monofilament mesh for plastic and reconstructive surgery. The deal is valued up to $140 million.

Medtronic reaches milestone in study of pulsed-field ablation and mapping catheter for AFib

A randomized study of more than 450 patients with persistent atrial fibrillation is now underway. All patients have been treated, and their outcomes will be tracked for 12 months.

Amazon’s $3.9B acquisition of One Medical under review in Oregon

The state of Oregon is taking a hard look at the proposed acquisition of One Medical by Amazon. The deal is valued at $3.9 billion.

As FDA approaches decision on Alzheimer's drug, 2 deaths raise concerns

Japanese pharmaceutical company Eisai has denied that two deaths that have sparked concerns about a new Alzheimer's disease drug treatment are attributed to its trials.

FDA announces another recall for troubled heart device after multiple hospitalizations

This latest recall involves the device's driveline boot cover, which “can become stiff over time” and cause problems for clinicians. There have been 33 complaints since 2017 related to the issue.

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