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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 Calls for Better Accuracy of Pulse Oximeters in People of Color
Pulse oximeters -- those tiny devices that measure blood oxygen levels with a quick clip to your finger -- may soon get a major upgrade to ensure they work just as well for people of all skin tones. The U.
FDA recommends fixing racial disparities in pulse oximeter readings
Experts say this call is critical to incentivizing manufacturers to fix racial disparities in the accuracy of the devices’ readings.
7h
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 ...
1h
on 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 ...
STAT
3h
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The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...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 MSN
16h
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.
22h
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.
1d
on 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.
BioSpace
3h
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 ...
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 ...
BioPharma Dive
22m
ALS drugs from Denali, Calico come up short, marking setback for Healey trial
Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the ...
BioSpace
5h
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, ...
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