Fierce Biotech November 17, 2023
Last fall, amid a mounting wave of evidence that many FDA-cleared pulse oximeters produce inaccurate results for people with darker skin, the agency convened a panel of experts to discuss possible solutions. A year later, with no major regulatory changes to show for it, half of the U.S.’ state attorneys general signed a letter Nov. 1 calling on the FDA to “act with urgency” to eliminate that inequity.
The nudge came at the right time: This week, the regulator announced that it plans to host another panel meeting about the issue early next year and, in the meantime, has published a discussion paper to collect feedback from the public that may help inform the meeting—though an FDA spokesperson clarified to...
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