FDA Issues Draft Guidance for Improving Skin Tone Disparities of Pulse Oximeters
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin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 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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.
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.
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FDA Issues Draft Guidance on AI-Enabled Medical Devices
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
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FDA kicks off new year with draft guidance on skin biopsies in trials
The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the ...
FDA issues draft guidance on developing weight loss drugs
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FDA draft guidance on labeling of plant-based foods ‘unfairly burdensome,’ says PBFA
The FDA does not favor commonly used descriptors such as ‘plant-based burger' on labels and suggests brands instead say ...
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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 ...
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FDA Releases Draft Guidance for Labeling Plant-Based Animal-Derived Foods
Comment period is open for the public to review the new draft guidelines for labeling plant-based alternative foods.
FDA aims to stem AI device bias, boost transparency in draft guidance
The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...