FDA, 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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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.
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.
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin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 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.
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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either use the newly developed Monk Skin Tone scale or another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.
FDA recommends fixing racial disparities in pulse oximeter readings
The agency is calling for the devices to be tested on significantly more people, as well those with darker skin tones, steps experts say are critical to incentivizing manufacturers to fix racial disparities in the accuracy of the devices’ readings.
Pulse Oximeters May Misread Oxygen Levels in People of Color. the FDA Wants to Change That
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for patients of color
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Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters

FDA, Lead

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.
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 ...
Ozempic 3.0? This drug causes the greatest weight loss — by far
Tirzepatide, a weekly GLP-1 and GIP drug, produced weight loss of up to 17.8% after 72 weeks. Semaglutide, a weekly GLP-1 ...
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 ...
verywellhealth2h
The Best Time to Take Fish Oil Supplements, According to Science
You can take fish oil at any time of day, but it's better to take it with a meal to reduce side effects. There are also ...
6abc News3h
Costco recalls Kirkland Signature brand cold and flu medicine for possible contamination
CHICAGO -- Costco is recalling a popular cold and flu medication sold at the end of 2024. The company is recalling Kirkland ...
Hosted on MSN2h
FDA grants ODD to NMD Pharma’s Charcot-Marie-Tooth disease therapy
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to NMD Pharma’s oral lead development programme, NMD670, designed to treat Charcot-Marie-Tooth disease (CMT). A ...
FiercePharma3h
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...