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 approves Bayer's finerenone to treat wide range of heart failure patients
Finerenone, sold by Bayer under the brand name Kerendia, is now approved in the United States for the treatment of HFmrEF and HFpEF. The drug has already been used for years to treat patients with chronic kidney disease and type 2 diabetes.
FDA details multiple Class I recalls for Edwards Lifesciences surgical devices
Edwards Lifesciences has recalled more than 61,000 medical devices due to the risk of a small piece of wire becoming exposed. No patient injuries have been reported at this time.
The FDA has cleared more than 1,200 clinical AIs—and submissions are increasing
In the past year, there has been a record number of new medical AI submissions, resulting in 300 new clinical AI clearances. The number of submissions has been steadily rising over the past decade.
AI algorithm that diagnoses depression from MRI scans gains key regulatory approval
Experts are hopeful the software can bring more objectivity to the diagnostic process by giving providers visual evidence of alterations in brain activity.
Software glitch triggers FDA recall of nearly 2,000 GE SPECT and CT systems
According to the notification, the issue can cause the scanners to inadvertently move during imaging.

ultrasound appendix appendicitis pediatric imaging

Study unearths low compliance and high outpatient imaging price variability at children’s hospitals

An MRI of the brain, for instance, could run for $1,693, a more than sevenfold difference from Medicare’s $230 rate.

Radiology leaders speak out in support of Ukraine

In the wake of Russia’s invasion of Ukraine, leaders in the radiology community are speaking out and publicly denouncing the aggressions.

Biden administration outlines next steps following surprise billing ruling in Texas

The Departments of HHS, Labor and Treasury said they are reviewing the decision and taking several actions to conform with the court’s action.

FDA issues new guidance on appealing decisions that adversely impact mammography accreditation

The U.S. Food and Drug Administration detailed instructions on how breast imaging providers can appeal decisions related to their accreditation and certification.

CT scan showing lung cancer nodules with measurements of each nodule to track growth or regression from treatment. Image courtesy of RSNA

ACR outlines changes in Medicare lung cancer screening coverage

The American College of Radiology recently released a detailed summary of the National Coverage Determination related to screening for lung cancer with low dose CT.

About 100 medical societies ask Congress to be involved in Congressional efforts to reform Medicare

Nearly 100 professional healthcare societies have asked Congress to include them in any discussions related to Medicare reform.

'Major victory': Texas physicians score key court win in national fight over surprise billing ban

Radiologists praised the ruling while AHIP, the nation's largest health insurance lobbying group, called it "misguided."

Proposal would pause radiologists’ student loan interest accrual, principal payments during residency

Proponents said the bipartisan bill would save residents thousands of dollars on interest and ease financial stress for those unable to begin repaying debt immediately.

Policy & Regulations

FDA approves Bayer's finerenone to treat wide range of heart failure patients

FDA details multiple Class I recalls for Edwards Lifesciences surgical devices

The FDA has cleared more than 1,200 clinical AIs—and submissions are increasing

AI algorithm that diagnoses depression from MRI scans gains key regulatory approval

Software glitch triggers FDA recall of nearly 2,000 GE SPECT and CT systems