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FDA, skin tone and Blood Oxygen Monitor
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 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.
FDA sets 1st voluntary limits on lead in children's food
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 disappoints child advocates with its new limit on lead in baby food
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.
FDA limits toxic lead in baby foods, aims to reduce exposure by up to 30%
The new guidance comes more than a year after lead-tainted pouches of apple cinnamon puree sickened more than 560 children in the US between October 2023 and April 2024, according to the CDC.
18h
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.
18h
on MSN
FDA seeks to boost blood oxygen monitor accuracy across skin tones
The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...
CNET on MSN
8h
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.
17h
on MSN
Sandwich Recall Update as FDA Sets Highest Risk Warning
Cucumbers potentially contaminated with salmonella could cause "serious adverse health consequences or death," the FDA warned ...
BioPharma Dive
21h
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
20h
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
2d
on MSN
Ex-FDA chief says Biden ‘mishandling’ bird flu, urges swift action from Trump
Scott Gottlieb and Luciana Borio, a former director for medical and biodefense preparedness policy at the National Security ...
Food Safety News
1d
FDA warns Stew Leonard’s Holdings over misbranded cookie products following anaphylactic death
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
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Food and Drug Administration
skin tones
pulse oximeters
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