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

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

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

When developing a new medical device or wearable technology, navigating the FDA regulatory pathway can be complex and resource-intensive....