Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...

After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either ...

The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and ...

The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...

Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's ...

Because of the risks biopsies can pose to patients, the FDA recommends only requiring them as part of trial participation if ...

But consumer advocates say the Food and Drug Administration's new guidance on lead limit in baby food doesn't go far enough.

For the first time, the US Food and Drug Administration has set a limit on the amount of lead that can be in baby foods, but critics say it’s too little, too late.