FDA Food and Drug Administration

FDA, skin tone and Pulse oximetry

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 · 3h

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.

Star Tribune · 1h

FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone

New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the devices.

Reuters · 3h

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.

Daily Journal · 5h

FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones

Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters

1hon MSN

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 ...

45mon MSN

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 ...

2hon MSN

FDA sets new lower levels for lead in baby food — critics say that’s not enough

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.

STAT4d

Save the Food and Drug Administration by breaking it up

Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...

10hon 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.

Modern Healthcare6h

FDA drafts guidance for AI developers

The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...

STAT3h

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 ...

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.

3don MSN

Pharma giant seeks to join lawsuit against FDA over weight loss drugs

Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...

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