FDA Proposes Updated Recommendations to Help Improve …
Jan 6, 2025 · This draft guidance, Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations, applies to certain pulse oximeters ...
FDA issues draft guidance to improve accuracy of pulse oximeters …
Jan 6, 2025 · A separate study of about 7,000 Covid-19 patients, also published in 2022, found that compared with White patients, blood oxygen levels measured using pulse oximetry were overestimated by an ...
Pulse oximeters may misread oxygen levels in ... - Associated Press News
Jan 6, 2025 · WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color, under a new federal proposal released Monday.. The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are ...
FDA updates guidance on pulse ox devices used in healthcare
Jan 7, 2025 · The agency then scheduled public meetings last year to reassess its existing pulse oximetry guidance. ... In response, a spokesperson for FDA told Healthcare IT News in July that it was still engaging stakeholders and gathering input from clinical researchers to inform the update. Previously, the FDA said on its Center for Devices and ...
FDA recommends fixing racial disparities in pulse oximeter …
Jan 6, 2025 · The Food and Drug Administration on Monday proposed a long-awaited plan aimed at improving how pulse oximeters work on people with darker skin — an effort that comes years after research showing ...
FDA pulse oximeter guidance aims to improve accuracy for …
Jan 6, 2025 · Previous guidelines asked for 200 data points; the new guidelines suggest manufacturers submit 3,000; they also increase the suggested sample size for studies of pulse oximeters from 10 people to ...
Decades-Old Problem Of Pulse Oximetry Across Skin Tones
Jan 7, 2025 · A similar finding was made in the 2023 JAMA Network Open study, concluding that the inaccuracies in pulse oximetry readings “led to delayed recognition of need for COVID-19 therapy among Black ...
FDA’s promised rules on pulse oximeters unlikely to end decades …
Oct 7, 2024 · State attorneys general and U.S. senators have pressed the FDA to take steps to eliminate pulse oximetry's racial bias, which has caused delays in treatment and worse health outcomes, and...
FDA's promised guidance on pulse oximeters unlikely to end …
Oct 17, 2024 · State attorneys general and U.S. senators have pressed the FDA to take steps to eliminate pulse oximetry's racial bias, which has caused delays in treatment and worse health outcomes, and...
CDRH Takes Steps to Advance Further Discussions on Pulse …
Nov 16, 2023 · Taken proactive steps to improve premarket evaluation strategies and equitable device performance to help improve the accuracy of pulse oximeters across all U.S. patient populations and...