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

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 ...

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 ...

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 ...

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 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.

Published on June 18, 2024, this rule revises requirements around current good manufacturing practice (CGMP), post-marketing ...

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 ...