FDA Proposes Updated Recommendations to Help Improve …
Jan 6, 2025 · Using both subjective (Monk Skin Tone Scale) and objective (calculation of individual typology angle) methods for more standardized evaluation of study participants’ skin …
FDA Calls for Better Accuracy of Pulse Oximeters in People of Color
6 days ago · Enrolling at least 150 patients with diverse skin tones in clinical studies. Increasing representation of patients with darker skin to at least 25% in each study, up from 15% ...
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
Jan 6, 2025 · 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 …
FDA issues draft guidance to improve accuracy of pulse oximeters …
6 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 …
U.S. regulator aims to improve accuracy of blood oxygen devices …
Jan 6, 2025 · 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 …
FDA Issues Draft Guidance for Improving Skin Tone Disparities of …
5 days 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 …
FDA pulse oximeter guidance aims to improve accuracy for …
Jan 6, 2025 · Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale …
Why pulse oximeters are still inaccurate on darker skin tones - STAT
Nov 1, 2024 · The devices overestimate blood oxygen in people with darker skin tones, making them appear healthier than they are.
Teledermatology study exposes skin tone diagnosis gaps, AI …
Feb 7, 2024 · Specialized and general physicians show significant gaps in diagnosing skin diseases across skin tones, with deep learning assistance improving accuracy but also …
How your skin tone could affect your meds | UCR News | UC …
Oct 10, 2024 · Skin pigmentation may act as a “sponge” for some medications, potentially influencing the speed with which active drugs reach their intended targets, a pair of scientists …