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But the FDA makes clear it expects to see new diversity data from manufacturers requesting approval for changes or updates to older oximeters. Monday’s announcement is only a draft. The FDA said it will take public comments on its proposal for 60 days before beginning work on a final version. ___
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 conduct larger studies and include more patients from different racial groups.
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 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 ...
NEW YORK (AP) — The clip-on devices that use light to measure oxygen levels in the blood are getting a The post FDA advisers meet on racial disparities in pulse oximeters appeared first on TheGrio.
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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