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.

ACR sees burden and little benefit from CMS’s plan to tackle ‘excessive radiation dose’

The American College of Radiology is "urgently" asking that the agency rename the measure, worried that it could be spreading misinformation.

FDA clears and grants breakthrough status for radiology triage tool from Annalise.ai

The Sydney, Australia-based vendor said its solution enables both passive and active notifications for suspected obstructive hydrocephalus.

Radiology groups urge CMS to retool the flawed Merit-based Incentive Payment System

Leaders with ACR, the RBMA and Radiology Partners all have recently written about concerning aspects of the quality-focused Medicare payment program.

FDA announces recall of Abbott neurostimulation devices after MRI-related issues lead to 73 injuries

The new recall, which includes more than 155,000 implantable pulse generators, is due to ongoing issues with the devices being unable to exit MRI mode and return to normal use.

ACR, others push for imaging-agent pay fix as House leaders plan hearing on topic

The House Energy and Commerce Committee announced Tuesday that it will hold a hearing to discuss the FIND Act.

Video of Denise Garris, ASE regulatory consultant and principal of the Korris Group, explaining how reimbursements from insurance andMedicare work to pay or cardiac ultrasound exams. #ASE #ASE360 #ASE23 #ASE2023 #healthcarereimbursment

Understanding reimbursements and coding for echocardiography

"I think everyone would agree that the current fee-for-service model is not working appropriately and there needs to be a fix," regulatory consultant Denise Garris explained in a new interview.

Radiology Business Management Association warns CMS that specialty is reaching a ‘tipping point’

“After 16 straight years of cuts to radiology this is an unsustainable environment in medicine,” RBMA Executive Director Bob Still wrote to the agency.

Industry Watcher’s Digest

Buzzworthy developments of the past few days.

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