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

The FDA recommendations apply to only professional oximeters used in hospitals, doctor's offices, and other medical settings.

New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.

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

The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

The FDA does not favor commonly used descriptors such as ‘plant-based burger' on labels and suggests brands instead say ...

The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the invasive procedure and gaining assent and consent from children ahead of trials ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

Comment period is open for the public to review the new draft guidelines for labeling plant-based alternative foods.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...