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 federal proposal released Monday.  The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen. The FDA said it wants companies to …

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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones

The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.

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U.S. regulator aims to improve accuracy of blood oxygen devices for range of skin tones

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 federal proposal released Monday. The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals […]

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Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.

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By Jacqueline Howard, CNN (CNN) — Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased. Pulse oximeters are small finger-clamp devices that estimate how much oxygen is being carried in the blood. Available both over the counter and by prescription, they grew in po…

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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.  The long-awaited guidance released Monday comes in response to mounting evidence that the devices, which are used to quickly estimate a person’s blood…

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New FDA guidance aims to improve accuracy of pulse oximeters for people of color

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Manufacturers of medical devices that quickly measure oxygen levels in the blood would need to collect additional data to demonstrate that their products work for dark-skinned people, according to a new proposal by the US authorities published on Monday.

Los fabricantes de dispositivos médicos que miden rápidamente los niveles de oxígeno en la sangre tendrían que recopilar datos adicionales para demostrar que sus productos funcionan para personas de piel oscura, según una nueva propuesta de las autoridades estadounidenses publicada el lunes.

EEUU: Fabricantes de oxímetros deben realizar más estudios sobre resultados con piel oscura

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USA: Oximeter manufacturers need to conduct more studies on dark skin results

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 federal proposal released Monday.

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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.

Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that

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