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The Medical Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) recently met to review the reported inaccuracy of pulse oximetry in patients with darker skin. The meeting ...
The accuracy of pulse oximeters for people with dark skin tones is now being reviewed. An FDA advisory panel met Friday to talk about how to make these devices more accurate for people with darker ...
Story at a glance FDA panel meets to discuss pulse oximeters, which are medical devices that measure blood oxygen levels. Studies have suggested that oximeter readings are less accurate for people ...
A pulse oximeter probe applied to a person's finger. A pulse oximeter is a medical device that indirectly monitors the oxygen saturation of a patient's blood (as opposed to measuring oxygen saturation directly through a blood sample) and changes in blood volume in the skin, producing a photoplethysmogram that may be further processed into other measurements. [4]
The longstanding problem of pulse oximeters providing less-accurate readings for people with dark skin tones got another look Friday from a panel of experts for the US Food and Drug Administration.
In April 2023, the company received FDA approval for a pulse oximetry-based device for preventing opioid overdose by providing alerts of respiratory depression. The device—which was the subject of an innovation challenge issued by the FDA—received a De Novo classification allowing it to be distributed over-the-counter and through ...
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