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FDA, Pulse oximetry

CNN on MSN · 2d

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.

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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin

FDA limits toxic lead in baby food

The FDA Set Guidelines for 'Acceptable' Levels of Lead in Baby Food for the First Time — but Some Experts Say It's Not Enough

On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an acceptable level of lead in processed baby food, including canned fruit and vegetables, yogurts, ready-to-eat purées, and cereals.

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US FDA issues guidelines to reduce lead levels in baby foods

The FDA’s action, serving only as non-enforceable guidance, has been criticised by the NGO Center for Science in the Public Interest as insufficient.

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’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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...

1don MSN

FDA issues draft guidance on developing weight loss drugs

The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new ...

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry ...

FDA issues draft guidance on marketing submissions for AI-enabled medical devices

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

Modern Healthcare2d

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 ...

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