Engineering leaders developing physiological monitoring devices often encounter references to “arterial line measurements” in validation standards and technical literature. Although arterial lines are invasive and placed in clinical environments, the data they generate is central to how the industry defines accuracy for non-invasive technologies.  This article explains what an arterial line is, why its measurements are considered a benchmark, and how arterial line data is use

Engineering Reliability: What CTOs Need to Know About Regulatory-Grade Physiological Monitoring Validation   CTOs in medical-device startups face an engineering challenge that extends far beyond hardware and firmware. The success of a physiological monitoring product—whether a pulse oximeter, blood pressure monitor, or wearable sensing platform—depends on rigorous clinical research studies capable of supporting FDA and CE mark submissions. The gap between early engineering va

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 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

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