FDA, skin tone

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 devices more reliable and less biased.
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with diverse skin tones.
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their performance across skin tones amid growing evidence that the current ones are not reliable for patients with darker skin.
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a major upgrade to ensure they work just as well for people of all skin tones. The U.
FDA recommends fixing racial disparities in pulse oximeter readings
Experts say this call is critical to incentivizing manufacturers to fix racial disparities in the accuracy of the devices’ readings.
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
The Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients of color during the pandemic.
New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones. The long-awaited guidance released Monday comes in response to mounting evidence that the devices,

FDA limits toxic lead in baby food

FDA, RSV

Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market
The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...
Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
FDA weighs novel pain drug amid opioid crisis
The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...
Cheese Puffs Recall as FDA Issues Risk Warning
The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.
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Leaving FDA, Califf is unapologetic — and warns of staff departures
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FDA approves Bismarck doctor's new catheter design
When Dr. Bruce Gardner saw first-hand how much harm a forcefully-pulled catheter can do to a patient, he decided to take ...
Advocates urging FDA to ban shock device used in Mass. school ASAP
There's an urgent push underway to get the U.S. Food and Drug Administration to finally ban the devices that administer ...
FDA Accepts Astellas Pharma's Revised SNDA For IZERVAY In Geographic Atrophy Treatment
Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration accepted the revised supplemental New Drug ...