Pulse oximeters may misread oxygen levels in people of color.
4 days ago · 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.
Pulse oximeters may have contributed to inequities in how …
1 day ago · Minnesota News You Can Use. The Latest. 18 minutes ago. ... So-called “health and wellness” pulse oximeters available online and at pharmacies — like the $50.99 CVS Health Pulse Oximeter ...
Pulse Oximeters May Misread Oxygen Levels in People of Color.
4 days ago · Anupam Nath. FILE - A health worker uses a pulse oximeter to check the oxygen saturation level of another after administering COVID-19 vaccine at a hospital in Gauhati, India, Jan. 21, 2021.
FDA issues draft guidance to improve accuracy of pulse oximeters …
4 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 Calls for Better Accuracy of Pulse Oximeters in People of Color
3 days ago · Over-the-counter oximeters, often marketed as "general wellness" devices, are not affected. The FDA's recommendations come after studies, including one from 2021, found that pulse oximeters often overestimate oxygen levels in Black patients, potentially delaying treatment and increasing health risks, a news release states.
FDA updates guidance on pulse ox devices used in healthcare
3 days ago · The guidance, Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations, suggests new performance information in product labeling and applies only to certain pulse oximeters used primarily for medical purposes in hospital settings or doctors’ offices, FDA said in ...
FDA Proposes Updated Recommendations to Help Improve …
5 days ago · The FDA has previously informed patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of ...
FDA recommends fixing racial disparities in pulse oximeter …
4 days ago · 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’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 panel examines evidence that pulse oximeters may not work …
Nov 1, 2022 · Pulse oximeters are used to check blood oxygen saturation levels and heart rate, but research suggests these devices may be less accurate in individuals with darker skin pigmentation.
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