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Unmasking Occult Hypoxemia: Lessons from COVID-19 for Device Validation and Inclusive Monitoring
The Hidden Measurement Problem Behind COVID-19 Hypoxia During the height of the COVID-19 pandemic, clinicians encountered a puzzling trend: individuals with dangerously low arterial oxygen levels often appeared clinically stable and comfortable. While “silent” or “happy” hypoxia drew headlines, an equally critical issue— occult hypoxemia —posed a more subtle risk. Occult hypoxemia occurs when pulse oximetry readings overestimate true arterial oxygen saturation (SaO₂), mas
Oct 283 min read


Beyond the Surface: Pulse Oximetry Accuracy in Darkly Pigmented Skin Tones
A Persistent Problem Hidden in Plain Sight For decades, pulse oximetry has served as a cornerstone of clinical monitoring—offering a quick, noninvasive estimate of blood oxygen saturation (SpO₂). Yet, the COVID-19 pandemic exposed a long-standing and underappreciated flaw: pulse oximeters can overestimate oxygen levels in individuals with darker skin pigmentation . Inaccurate SpO₂ readings may mask hypoxemia , delay treatment decisions, and contribute to existing health di
Oct 213 min read


Recruiting the Right Participants for Medical Device Validation Studies
Developing and validating physiological monitoring devices requires more than engineering excellence. The reliability of study...
Sep 192 min read
The Importance of FDA-Approved Pulse Oximeters
Why Accuracy in Oxygen Monitoring Matters Pulse oximeters are among the most widely used medical devices in hospitals, clinics, and...
Sep 22 min read


The Equity Gap in Medical Device Performance
Medical devices that rely on optical sensing—such as pulse oximeters —measure physiological signals by analyzing light as it passes...
Aug 192 min read
Hypoxia Testing: A Critical Step in Medical Device Validation
For developers of pulse oximeters, respiratory monitors, and other physiological sensors, validating device performance under reduced...
Aug 132 min read
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