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 announces full recall of Baxter Life2000 ventilators over cybersecurity flaw
All models and lot numbers of the units are subject to the recall. The security vulnerability could allow an unauthorized person to access and control the pumps, posing a serious health risk to patients.
Reimbursement for AI-based plaque assessments is improving
A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen.
Medtronic recalls data management software, urging healthcare providers to run update
The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.
Radiology societies urge caution when implementing AI in pediatric imaging
Six professional organizations including the Society for Pediatric Radiology made their case in a joint statement published across multiple medical journals Nov. 25.

FDA updates and rescinds several radiation protection recommendations

According to the Federal Register, the FDA is repealing these radiation protection recommendations because they have become “outdated” and “unnecessary.”

FDA announces new IABP recall after 4 serious injuries, 1 death

The new recall includes nearly 4,500 devices. There have been 134 incidents so far, including 5 adverse events.

Majority of Americans believe healthcare is a government responsibility

More than half of Americans (57%) believe healthcare should be ensured by the federal government, according to a recent poll from Gallup.

FDA proposes major shift to COVID vaccine schedule

Under the new proposal, the FDA would conduct an assessment of prevalent strains circulating each year, likely beginning around June, with the aim of new vaccines being ready by September.

EU organizes aggressive anti-cancer action around imaging

The executive branch of the European Union has launched a major project to aggregate cancer imaging data from across the continent so it can be readily tapped by healthcare providers, medical schools and industry innovators.

Gun goes off during MRI, injuring patient's son

A 40-year-old man was accompanying his mother to her MRI exam when the magnet caused his gun to fire, shooting him in the abdomen.

FDA approves new medication for type 2 diabetes

The newly approved SGLT2 inhibitor, bexagliflozin, is marketed under the name Brenzavvy. It is not recommended for patients with type 1 diabetes.

High hopes still afloat as promising Alzheimer’s drug loses bid for accelerated approval

The FDA has declined to accelerate approval of Eli Lilly’s highly anticipated Alzheimer’s drug, but the reason for the rejection may presage a forthcoming thumbs-up.

Policy & Regulations

FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw

Reimbursement for AI-based plaque assessments is improving

Medtronic recalls data management software, urging healthcare providers to run update

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

Radiology societies urge caution when implementing AI in pediatric imaging