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. 

medical debt

Judge overturns Biden-era rule that curbed medical debt reporting after CFPB backs off

The Consumer Financial Protection Bureau joined trade lobby groups in asking a federal court to vacate the rule, which would have forbidden creditors from considering medical debt in lending decisions.

Doctor accused of forging vaccine cards and injecting children with saline has all charges dropped

Under the direction of U.S. Attorney General Pam Bondi, charges against Michael Kirk Moore Jr., MD, were dropped just as his trial began. He had been accused of destroying 1,937 doses of COVID-19 vaccines and accepting kickbacks for falsifying vaccine records.

Bayer finerenone Kerendia heart failure MOONRAKER

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 AI enabled Dental Image Analyzer from DentalMonitoring uses a smartphone to scan a patient's mouth and the AI reconstructs a complete model of the mouth to compare with prior images to track the progress of orthodontic work at home. The FDA cleared the technology in cleared 2024. Photo by Dave Fornell Vivian Fornell

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.

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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. 

The Medtronic Symplicity Spyral Renal Denervation system uses a catheter that curls in the renal artery to place radiofrequency electrodes against the vessel wall to ablate the nerves that control vasodilation, so the artery can be propped in the fully open position.

CMS proposes Medicare coverage for renal denervation

This proposal, if finalized, would dramatically increase patient access to renal denervation. Both Recor Medical and Medtronic have shared their excitement over the news.