FDA Proposes Updated Recommendations to Help Improve …
3 days ago · Using both subjective (Monk Skin Tone Scale) and objective (calculation of individual typology angle) methods for more standardized evaluation of study participants’ skin tone and accurate ...
FDA Issues Draft Guidance for Improving Skin Tone Disparities of …
13 hours ago · The executive summaries of both explained ongoing concerns that the devices are not accurate across all skin tones and reviewed adverse events that have been reported in real-world patients due to inaccurate readings. ... Stay up-to-date with breaking news, conference slides, and topical videos covering the spectrum of CVD. Join our newsletter! ...
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
2 days ago · The FDA's recommendations, which aim to tighten regulatory oversight, include clinical studies involving at least 150 participants with diverse skin tones, ensuring that at least 25 percent of ...
FDA issues draft guidance to improve accuracy of pulse oximeters …
2 days ago · 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 ...
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
2 days ago · 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 ...
FDA pulse oximeter guidance aims to improve accuracy for …
2 days ago · The agency called on manufacturers to gather clinical data showing the efficacy of these devices on all skin tones and submit that data and a new label showing the device performs well on all skin ...
US FDA issues new draft guidance aimed to help improve …
1 day ago · Some key elements of the FDA’s draft recommendations include: Gathering clinical data (e.g., controlled desaturation laboratory study or, in certain cases, real-world data) to evaluate device performance accuracy across the range of skin pigmentations; Increasing the number of clinical study participants; Using both subjective (Monk Skin Tone ...
U.S. regulator aims to improve accuracy of blood oxygen devices …
2 days ago · The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.
FDA recommends more robust testing of pulse oximeters to avoid …
2 days ago · The new guidance recommends companies test the devices in patients with wider ranges of skin tones, including from three subgroups of the 10 levels in the subjective Monk Skin Tone scale.
FDA panel recommends more diversity in pulse oximeter trials
Feb 3, 2024 · The longstanding problem of pulse oximeters providing less-accurate readings for people with dark skin tones got another look Friday from a panel of experts for the US Food and Drug...
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