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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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.
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Oximeters were a critical part of emergency care for patients with COVID-19 during the pandemic. But several studies have suggested that darker skin pigmentation can sometimes thr
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.
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FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
Sentynl took over the therapy’s development and commercialisation from Fortress Biotech's subsidiary Cyprium Therapeutics.
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Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
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 ...
FDA Sets New Levels for Toxic Lead in Baby Food
The FDA's new standards for toxic lead target processed baby foods such as jarred fruits, vegetables, yogurts and dry cereals ...
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FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
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.
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Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food
The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods ...
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MoCRA Guidance Update for Registration and Listing of Cosmetic Product Facilities and Products
What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of ...
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.
Pharma giant seeks to join lawsuit against FDA over weight loss drugs
Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...