FDA, Pulse oximetry

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FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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.
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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin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 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Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters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 releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Responding to complaints that pulse oximeters that measure blood oxygen levels are less accurate in people with darker skin tones, the Food and Drug Administration Monday released long-awaited guidance proposing how manufacturers should test and label these devices.

FDA, Lead and The U.S. Food

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 ...
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 ...
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 ...
Applied Therapeutics, Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky for More Information – APLT
NEW YORK, NY / ACCESSWIRE / January 6, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to ...
No, Thomas Jefferson did not write the prayer Speaker Mike Johnson recited in the House
Following his reelection as speaker of the House, Mike Johnson recited a prayer he implied was written by Thomas Jefferson. But Jefferson didn’t write it.
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First US bird flu death reported in Louisiana, health officials say
Louisiana has reported the first bird flu-related death in the U.S. Here’s what health officials are saying about the case ...
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FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...