At a Medical Devices Advisory Committee meeting held Nov. 1, panelists recommended improvements to the FDA regarding pulse oximeters and their accuracy among patients with darker skin pigmentation.
Please provide your email address to receive an email when new articles are posted on . The FDA’s proposed changes to premarket pulse oximeter trial criteria were generally accepted by an advisory ...
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.
The Food and Drug Administration convened an advisory panel this month to discuss concerns that pulse oximeters may be less accurate in people with dark skin pigmentation. The agency asked panelists ...
As an emergency medicine physician, Dr. Owais Durrani sees this issue regularly first-hand: When he clamps a pulse oximeter onto a patient’s fingertip to measure their blood oxygen levels, the small ...
Clinical studies should also evaluate how pulse oximeters perform over time for different skin tones, such as how long it takes for the device to provide a steady, accurate reading, panel member Dr.