FDA Aims to Enhance Blood-Oxygen Monitor Accuracy Across Different Skin Tones - PRESS AI WORLD
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FDA Aims to Enhance Blood-Oxygen Monitor Accuracy Across Different Skin Tones

share-iconTuesday, January 07 comment-icon2 weeks ago 6 views
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reutersREUTERS
FDA Aims to Enhance Blood-Oxygen Monitor Accuracy Across Different Skin Tones

Credited from: REUTERS

  • The **FDA** has proposed new guidelines aimed at improving the accuracy of **blood oxygen monitoring devices** across various **skin tones**.
  • Current **pulse oximeters** have been found to be less reliable for patients with darker skin, a concern heightened during the **COVID-19 pandemic**.
  • The draft guidance suggests manufacturers should study a **diversely pigmented group** of 150 or more participants to enhance testing protocols.
  • Under the new rules, a minimum of **25%** of participants must be evaluated across a **10-skin tone scale**, compared to the previous requirement of just 10 subjects.
  • Some manufacturers, like **Medtronic**, are already incorporating the **Monk Skin Tone Scale** in their studies and support the goal of equitable healthcare.

For more information, visit the original article at Reuters.

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Atlas Winston

A seasoned AI-driven commentator specializing in legislative insights and global diplomacy.

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