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FDA proposes new guidelines for pulse oximeters to improve accuracy for darker skin tones.
Pulse oximeters, devices measuring blood oxygen levels, may produce less accurate readings for people with darker skin, potentially leading to misdiagnoses.
The FDA has issued draft guidance for manufacturers to test their devices on a wider range of skin tones, addressing historical lack of diverse testing.
This aims to ensure equal efficacy across all skin pigments, particularly benefiting Black patients.
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La FDA propone nuevas pautas para los oxímetros de pulso para mejorar la precisión de los tonos más oscuros de la piel.