FDA misses target date for releasing recommendations to make pulse oximeters more equitable. The widely used devices often don’t detect low oxygen levels in people with darker skin. Manage ...

The FDA said a large number of devices available over the counter “have not been evaluated by the FDA for use in clinical ...

Require the FDA to enforce restrictions on wellness centers, alternative medical spas and other health centers from promoting the use of hyperbaric oxygen therapy for conditions that are not FDA ...

In 2021, the FDA warned doctors about potential inaccuracies with oximeters after a study found the devices tended to overestimate Black patients' oxygen levels, which could lead to delays in ...

The FDA proposes new guidelines for blood oxygen monitors to improve accuracy across skin tones. Manufacturers should test devices on a diverse group using the Monk Skin Tone Scale.

WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color, under a new ...

FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones. Published Jan 06, 2025 at 2:56 PM EST Updated Jan 06, 2025 at 10:37 PM EST. By .

The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site ...

In 2021, the FDA warned doctors about potential inaccuracies with oximeters after a study found the devices tended to overestimate Black patients' oxygen levels, which could lead to delays in ...

FDA seeks to boost accuracy of blood-oxygen monitors across skin tones. By Bhanvi Satija. January 6, 2025 8:50 PM UTC Updated ago Signage is seen outside of the Food and Drug ...