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.

Products from Avenda Health, Imagen Technologies, Ultromics OK’d for use in the US

An AI startup has been cleared to market a platform for precisely mapping prostate cancer with 3D visualization so the tumor can be treated without harm to healthy surrounding prostate tissue.

AI-powered platform for heart failure detection gains FDA clearance

According to data submitted to the FDA, the platform has been linked to an accuracy of 90%, sensitivity of 87.8% and specificity of 83%.

Cardiologists fear new regulations will cause a medical device shortage in Europe

Diagnostic catheters, ablation catheters and stents are just some of the solutions cardiologists are now struggling to obtain.

Alternative therapies for heart failure: Health experts detail the good, the bad and the unknown

A new scientific statement from the American Heart Association examined the potential impact of many therapies, including fish oil supplements, lily of the valley and yoga.

VIDEO: Impact of the 2023 Medicare cuts on radiology

Ed Gaines, JD, vice president of regulatory affairs and industry liaison, Zotec Partners, discussed the impact of the 2023 Medicare Fee Schedule on radiology at RSNA 2022 in Chicago last week. RSNA and several other medical societies say the cuts are not sustainable.

Healthcare groups react to prior authorization proposed rule

Healthcare groups are largely excited by a new proposed rule from the Centers for Medicare and Medicaid Services (CMS) that aims to streamline prior authorization and reduce burden on healthcare providers.

Ed Gaines, JD, CCP, vice president of regulatory affairs and industry liaison, Zotec Partners, discusses the No Surprises Act on radiology at the Radiological Society of North America (RSNA) 2022 meeting. Gaines works with RSNA on billing and Medicare issues and spoke in sessions at the RSNA 2022 meeting. Insurance companies have weaponized the No Surprises Act in an effort to cut their costs, he said.

VIDEO: Insurance companies have weaponized the No Surprises Act, may impact patient care

Ed Gaines, JD, CCP, vice president of regulatory affairs and industry liaison, Zotec Partners, discusses the impact of the No Surprises Act on healthcare and medical imaging at the RSNA 2022 meeting

CMS proposes rule on prior authorization

Prior authorization, which requires healthcare providers to get approval from insurance providers before giving certain treatments to patients, has been long-hailed as extremely burdensome to physicians, even causing delays in patient care.

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