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

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

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

New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...

Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon ge ...

Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...

Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

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

Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color ...

Hundreds of thousands of people trust Onyx, the first self-contained digital fingertip pulse oximeter. Incorporating the electronics and sensor into one unit – the easy-to-use Onyx provides a ...

The FDA has published a set of long-awaited recommendations to the industry to help ensure that pulse oximeters work correctly across all skin tones. | The FDA has published a set of long-awaited ...