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 ...

New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood. Story by Victor Stefanescu, The Minnesota Star Tribune • 1d.

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 ...

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 ...

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 ...

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 U.S. Food and Drug Administration is due to review data on deramiocel, a cell therapy up for approval for heart disease ...

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 ...