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 outlines coverage benefits for coronavirus

CMS has issued Frequently Asked Questions to provide more information on essential health benefits coverage of the new coronavirus, COVID-19, outbreak.

Most expensive drugs in the U.S.

Drug prices in the United States are higher than anywhere else in the world, and there are some prescription medicines with price tags in the millions.

Survey says: U.S. hospitals have big plans for automation

Nearly two-thirds of hospitals are hoping to implement robotic process automation and AI technologies in the next two years, according to a new survey of healthcare executives.

RadNet canceling nonessential travel, implementing new center protocols in response to COVID-19

The Los Angeles-based imaging giant has also revised sick leave policies and encouraged its 8,000 employees to work from home, where possible, to limit exposure.

Patients are comfortable with AI-powered cancer screening, but still want input from physicians

Patients are on board with AI-powered skin cancer screening, according to a new study published in JAMA Dermatology. But relationships with human physicians remain a priority.

Trump sends drug pricing reform principles to Congress

President Trump has sent his wish list of drug pricing reform priorities to Capitol Hill.

Industry reactions to interoperability rule are a mixed bag

A set of new rules that aim to improve the interoperability of healthcare records and set a string of new requirements on healthcare providers was met with mixed reactions across the industry.

CVS Health acquires 110 Midwest pharmacies

CVS Pharmacy is acquiring 110 pharmacies in the Midwest through a definitive agreement to take over Schnuck Markets' retail and specialty pharmacy businesses. An acquisition price and other financial details were not disclosed.

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