Introduction: The Foundation of Reliable Oxygenation Research   Controlled desaturation studies are central to validating  pulse oximeters . These studies, performed in specialized hypoxia laboratories  such as PRL, safely lower arterial oxygen saturation (SaO₂) to predefined plateaus, typically from %100 to 70% SaO₂, generating reference data used to calibrate or verify pulse oximeters.  At the core of this process lies one indispensable element: accurate blood gas analysis

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

The Growing Importance of Precision in Oxygen Monitoring   From hospital wards to fitness wearables, pulse oximeters  have become indispensable tools for noninvasively measuring blood oxygen saturation (SpO₂). Yet the accuracy of these devices, particularly across diverse skin tones and environmental conditions, has come under scrutiny in recent years.  As regulatory bodies and clinical researchers call for more inclusive and transparent validation, the need for a specialized

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

Introduction: A New Standard on the Horizon   On January 6, 2025 , the FDA released a draft guidance  titled Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations . This draft guidance updates and expands upon earlier 510(k) and performance expectations for pulse oximeters, placing renewed emphasis on accuracy across skin pigmentation  and non-disparate performance .   Crucially, the draft does

Developing and validating physiological monitoring devices requires more than engineering excellence. The reliability of study...

Why Arterial Line Monitoring Matters in Research   When evaluating new medical devices—particularly those designed for physiological...

Why Accuracy in Oxygen Monitoring Matters   Pulse oximeters are among the most widely used medical devices in hospitals, clinics, and...

Medical devices that rely on optical sensing—such as pulse oximeters —measure physiological signals by analyzing light as it passes...

For developers of pulse oximeters, respiratory monitors, and other physiological sensors, validating device performance under reduced...