FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.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,
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 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.
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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.
FDA Sets New Levels for Toxic Lead in Baby Food
The FDA's new standards for toxic lead target processed baby foods such as jarred fruits, vegetables, yogurts and dry cereals ...
FDA approves first ever medication for obstructive sleep apnea — here's what that means
Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea.
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FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
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 ...
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 ...
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 ...