On January 7, 2025, the FDA released the long-awaited draft guidance on “Pulse Oximeters for Medical Purposes—Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission ...

Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...

Previously, Medtronic hired third-party firms to carry out pulse oximeter testing, an executive recently told the Minnesota Star Tribune. Medtronic said it has been conducting a clinical study ...

The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

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 ...

The Food and Drug Administration's recommendations apply to pulse oximeters, which are clip-on devices used ... Enrolling at least 150 patients of different skin tones in clinical studies; — Including ...

This draft guidance, Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations, applies to certain pulse oximeters ...

Clinical studies must now include 25% of patients with darker skin tone Over-the-counter oximeters are not covered under the new guidelines TUESDAY, Jan. 7, 2025 (HealthDay News) -- Pulse ...