As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest ...

A research team led by Professor Kevin Tsia, programme director of the Biomedical Engineering Programme under the Faculty of Engineering of the University of Hong Kong (HKU), has developed an ...

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

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 FDA recalled Marketside Broccoli Florets sold at Walmart due to listeria contamination. Consumers should discard affected products. Listeria poses severe health risks, particularly for vulnerable ...

The Food and Drug Administration is warning that critical alerts from diabetes devices may fail to reach users, risking severe complications or death. The FDA sent out the warning about the smartphone ...

Opens in a new tab or window Some patients with diabetes may be missing critical safety alerts on their phones, the FDA warned on Wednesday. The agency said it has received reports of users of ...

how often and how the alerts are delivered (e.g. audible, vibration, text only) through the app on their phone. The FDA has received medical device reports in which users report these alerts are not ...

The Food and Drug Administration said Wednesday it has received multiple reports of users missing or not hearing important medical alerts from their phones, leading to cases of dangerously low ...