The firings appeared to focus on employees in the agency’s centers for food, medical devices, and tobacco products. The Trump ...

The cuts hit the FDA's medical device center particularly hard, including reviewers and experts on AI-enabled medical ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

The health authority issued a toxic drug alert for the city on Saturday, January 25th, saying the pills have been linked to “sudden overdoses requiring naloxone and/or hospitalization”.

This article discusses the Anti-Kickback Statute and the False Claims Act. "When coupled with the False Claims Act (FCA), the AKS turns into a potent civil enforcement tool that carries many of the ...

An AI tool appeared superior to two FDA-approved biomarkers for predicting how people with cancer will respond to immune ...

The Trump administration has instructed federal health agencies to pause all external communications, such as health advisories, weekly scientific reports, updates to websites and social media ...

The Food and Drug Administration is warning that critical alerts from diabetes devices may fail to reach users, risking ...

Mayo Clinic researchers have pioneered an artificial intelligence (AI) tool, called OmicsFootPrint, that helps convert vast amounts of complex biological data into two-dimensional circular images. The ...

According to the FDA, "Class I" level recalls are used when there is "reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or ...

U.S. officials are warning about a potentially life-threatening issue with smartphone apps that help manage diabetes.

After combing through 4,000 existing medications, an artificial intelligence tool helped uncover one that saved the life ... to determine that adalimumab—a monoclonal antibody which is FDA-approved to ...