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.

Kate Hanneman, MD, University Of Toronto, explains why vendors and hospitals are increasingly discussing lowing their carbon footprint by starting with radiology.

What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

SimonMed imaging centers avoided regulation, even after safety concerns

The chain of imaging centers was given a private practice exemption in Arizona, but it includes more than 60 different facilities.

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent Drug-Coated Balloon (DCB) for the treatment of coronary in-stent restenosis (ISR) in patients with coronary artery disease.

FDA approves Boston Scientific’s new drug-coated balloon for coronary in-stent restenosis

Interventional cardiologists have been anticipating this news for quite some time. The device, the first of its kind, provides an alternative treatment option to repeat PCI or cardiac surgery for patients with coronary ISR.

DOJ collects $1.9B from healthcare in 2023, with imaging provider making 1 of the biggest payouts

Cardiac Imaging Inc. agreed to pay $85 million in October, the largest judgment in the “Laboratory, Pathology, Radiology and Diagnostics" category.

Biosense Webster gained CE mark approval for its Varipulse pulsed field ablation (PFA) system in Europe

Biosense Webster gains CE mark approval for new PFA system

The news represents yet another big regulatory approval for PFA technology in 2024. Could FDA approval be next for Biosense Webster?

money cybersecurity ransomware health IT data breach hacker

Change Healthcare cyberattack having an ‘alarming’ impact on physician practices, advocates warn HHS

Since the issue arose on Feb. 21, providers in radiology and other specialties have experienced “substantial” billing and cash flow disruptions, MGMA reported Wednesday.

Court upholds decision to strip radiologist of license for performing cosmetic surgeries

Wade Banker, MD, disputes the allegations and is appealing the ruling.

Lawsuit accuses radiology AI vendor MIM Software of patent theft

Progenics Pharmaceuticals Inc. claims MIM stole its patents and used them to help entice GE HealthCare to buy the company in January.

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