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.

FDA limits use of Johnson & Johnson COVID-19 vaccine over blood clot risk

The move limits the vaccine to individuals 18 and older for whom other other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, as well as those 18 and older who would otherwise not receive a COVID-19 vaccine.

Radiologists should be aware of amyloid-related imaging abnormalities for patients taking Alzheimer's drug

Safety information for patients taking Aduhelm has been updated by the FDA to include the addition of two MRI scans during the first year of treatment.

Biden responds to leaked Supreme Court draft opinion overturning Roe v. Wade

President Joe Biden has responded to a leaked draft majority opinion that reveals the Supreme Court has voted to overturn Roe v. Wade, the court case that allowed legal abortion care in the U.S.

‘Virtual colonoscopy’ still struggling for mindshare

Two-thirds of U.S. adults eligible to get screened for colorectal cancer have recently completed an exam, but only 1.4% of them opted for CT colonography over optical colonoscopy or sigmoidoscopy.

Prior authorization under fire in Inspector General investigation

An investigation from the Office of the Inspector General (OIG) regarding prior authorization requirements in Medicare Advantage (MA) plans revealed concerns about access to care.

Imaging shows COVID vaccines effective at warding off pulmonary embolism

Researchers have found the condition significantly less among patients who received at least two doses of a COVID vaccine.

An example of COVID vaccine caused axillary adenopathy. The woman has a family history of breast cancer, but this lesion, seen on breast ultrasound, tested negative in an RSNA study.

Experts suggest new follow-up imaging protocols for vaccine-related lymphadenopathy

New research shows that persistent lymph node swelling observed on imaging can persist beyond 12 weeks post-vaccination for up to 50% of women.

More than 400 nursing homes expected to close this year

The 400+ closures projected for 2022 are nearly double the next highest year, when 220 nursing homes closed in 2019.

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