Dyshemoglobins and Pulse Oximetry: How COHb and MetHb Influence Measurement Accuracy   Pulse oximetry has become central to physiological monitoring across wearables, medical devices, and clinical research studies. Yet even the most advanced sensor architectures face fundamental challenges when hemoglobin exists in altered forms—known as dyshemoglobins . Carboxyhemoglobin (COHb) and methemoglobin (MetHb) change light absorption in ways that directly influence SpO₂ readings an

Accurate oxygen saturation measurement is foundational for modern physiological monitoring, especially for developers of pulse oximeters, wearables, and multiparameter platforms. Yet many devices fail to achieve regulatory expectations because their performance is never tested across the full range of oxygen saturation levels humans experience.  Controlled desaturation studies fill this gap, ensuring claims reflect real-world performance. These studies intentionally and safel

Transparent clinical operations have become a defining differentiator for high-performing contract research organizations. Yet many medical device and wearable developers still encounter opaque decision-making, limited protocol visibility, and communication gaps that slow execution and create unnecessary regulatory friction. The result is predictable: CRO risk mitigation becomes reactive instead of proactive , and promising technologies reach the FDA or CE mark later than the

Introduction: Inclusion Begins with Ethical Engagement   In clinical research, the term “vulnerable populations” describes individuals who may be at risk of coercion, manipulation, or harm due to limited autonomy, health literacy, socioeconomic disadvantage, or institutional dependence. Examples include individuals with cognitive limitations, students or employees under authority, people with limited language proficiency, or those experiencing social or economic marginalizat

Introduction: Verification Defines Trust in Pulse Oximetry Pulse oximeters are among the most widely used physiological monitoring devices—found in hospitals worldwide. Yet, behind every reliable SpO₂ reading lies a complex scientific process: verification against reference standards . Pulse oximeter verification studies (or pivotal studies) confirm how closely a device’s functional oxygen saturation (SpO₂) values align with the true arterial oxygen saturation (SaO₂), measure

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

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...