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Pulse Oximetry

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March 31, 2025
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Accurate pulse oximetry ‘challenging’ in critically ill patients; skin pigmentation a factor

CHICAGO — In a new study, pulse oximeters underestimated arterial oxygen saturation among patients in the ICU, and the ability of the devices to detect hypoxemia was especially hindered in patients with dark skin pigmentation.

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January 13, 2025
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FDA releases draft guidance on pulse oximeter study recommendations

The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform similarly in individuals with different skin pigments, according to a press release.

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January 10, 2025
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Diversity in pulse oximeter clearance summaries increases after 2013 FDA guidance

Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance summary documents discussing race and ethnicity/skin tone rose, according to a research letter published in JAMA.

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March 29, 2024
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Pulse oximeters overestimate oxygen saturation in darker skin pigments

Among individuals with darker skin tones, pulse oximeters often overestimated their oxygen saturation levels, according to a systematic review published in British Journal of Anaesthesia.

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February 06, 2024
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FDA panel: Proposed changes to pulse oximeter premarket studies generally well received

At a Medical Devices Advisory Committee meeting held Feb. 2, proposed changes to premarket studies assessing pulse oximeter performance were generally well received by the panelists.

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January 24, 2024
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Pulse wave amplitude drops help find patients with OSA at risk for cardiovascular events

Having a low pulse wave amplitude drop index was linked to a heightened risk for cardiovascular events in patients with obstructive sleep apnea, according to results published in American Journal of Respiratory and Critical Care Medicine.

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September 18, 2023
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Acetazolamide lowers prevalence of altitude-related adverse health effects in COPD

Acetazolamide taken during stays in high-altitude areas decreases the chances for altitude-related adverse health effects among patients with COPD, according to a European Respiratory Society International Congress presentation.

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August 30, 2023
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Inaccurate pulse oximetry readings delay COVID-19 therapy for Black patients

Pulse oximeters more frequently overestimated arterial oxygen saturation among Black patients hospitalized with COVID-19 compared with white patients, leading to delayed COVID-19 therapy, a recent study found.

News
June 21, 2023
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FDA grants 510(k) clearance to pulse oximeter device for infants

The FDA has granted 510(k) clearance to a prescription pulse oximeter in the form of a sock for monitoring oxygen saturation levels of infants, according to a manufacturer-issued press release.

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June 20, 2023
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Pulse oximeters may misjudge sleep apnea severity in Black patients

WASHINGTON — Black patients had decreased desaturation sensitivity during sleep recorded by pulse oximeters, according to research presented at the American Thoracic Society International Conference.

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