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FDA, Pulse oximetry

CNN on MSN · 3d

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin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.

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.

The Associated Press on MSN · 3d

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 dry cereal.

4hon MSN

New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood

At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...

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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...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 Updates Final Guidance on Cosmetic Facility Registration and Product Listing: Wiley

The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the 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 ...

2d

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 ...

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 ...

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