FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.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 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 ...
FDA sets limits on lead in some baby foods
But consumer advocates say the Food and Drug Administration's new guidance on lead limit in baby food doesn't go far enough.
FDA recommends fixing racial disparities in pulse oximeter readings
The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people ...
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Is It COVID or the Flu? Take This FDA-Approved, At-Home Test to Find Out
You don't need a prescription to purchase a test that will tell you whether you're sick with COVID or the flu.
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.
FDA disappoints child advocates with its new limit on lead in baby food
For the first time, the US Food and Drug Administration has set a limit on the amount of lead that can be in baby foods, but critics say it’s too little, too late.
FDA limits toxic lead in some baby foods
The Food and Drug Administration has set maximum levels for lead in baby foods like jarred fruits and vegetables, yogurts and ...
Sandwich Recall Update as FDA Sets Highest Risk Warning
Cucumbers potentially contaminated with salmonella could cause "serious adverse health consequences or death," the FDA warned ...
FDA seeks to boost blood oxygen monitor accuracy across skin tones
The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...
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FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...