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.

CMS will simplify prior authorization process that’s given radiologists headaches for years

Administrator Seema Verma recently revealed that her agency has identified such changes as a top priority in 2020.

Radiology societies urge Congress to halt $3B in proposed cuts to NIH

Twenty-four imaging advocacy groups are asking lawmakers to stave off any cuts to the National Institutes of Health, which funds numerous radiology-related research initiatives.

Fewer struggling to pay medical bills—surprise or not—but millions still set back

Citing data previously published from the National Health Interview Survey, authors Amy Cha, PhD, MPH, and Robin Cohen, PhD, point out that major medical bills piling up for one member of a family tend to weaken the entire household.

ACR applauds equitable surprise medical billing legislation

The House Ways & Means Committee unveiled its proposal earlier this month, which includes a mediation process that does not exclude providers based on an established qualifying threshold.

FDA clears ‘world’s first’ portable, low-cost MRI following positive clinical research

“We’ve flipped the concept from having to get patients to the MRI to bringing the MRI to the patients,” said senior author of the preliminary research, Kevin Sheth, MD.

Yale accused of age discrimination for subjecting older radiologists, other docs to competency testing

The EEOC has filed suit against the prestigious university’s teaching hospital for forcing physicians over age 70 to take vision and neuropsychological exams.

China ramps up AI surveillance in face of coronavirus outbreak

Big-name Chinese technology vendors have responded to the Wuhan coronavirus outbreak by using more AI surveillance on the general public than ever before.

Health impacts are mixed when the minimum wage is raised

Where to set the minimum wage, or whether to set one at all, is one of the most contentious political questions in these divided times. A new study focused on health outcomes may give argumentation ammunition to all sides.

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