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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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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.

Newsweek on MSN · 22h

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.

Minneapolis Star Tribune on MSN · 17h

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.

Yahoo · 20h

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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.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, lead

CBS News · 21h

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.

Yahoo · 6h

FDA limits toxic lead in some baby foods – here's what to know

The FDA has set maximum levels for lead in packaged processed foods sold in jars, pouches, tubs or boxes. Here's what to know.

Newsweek on MSN · 20h

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.

1hon MSN

Cheddar cheese listeria recall hits several states: FDA says avoid these Wicklow Gold products

New Jersey-based Abbey Specialty Foods is recalling cheddar cheese products due to fears of listeria contamination. Here’s ...

STAT3h

Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...

CNET on MSN16h

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.

BioSpace2h

When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance

Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...

1don MSN

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.

19h

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 ...

BioSpace5h

FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...

22h

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 ...

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 ...

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