regulator-ready clinical endpoints

Pulse oximetry validation across diverse skin tones to detect and mitigate occult hypoxemia.

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

Researchers performing controlled desaturation studies in a pulse oximeter device testing lab to validate SpO₂ accuracy across skin tones.

Inside a Pulse Oximeter Device Testing Lab: How PRL Ensures Accuracy, Inclusivity, and Regulatory Readiness

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

Oct 233 min read

Pulse oximetry sensors on diverse skin tones illustrating variability in SpO₂ accuracy.

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

Clinical research team ensuring high-quality data collection for medical device validation.

Why Data Quality Matters: Choosing the Right Clinical Research Service Provider

In clinical research for medical devices and wearable technologies, data quality is everything . Regulatory clearance depends not just on whether a study was conducted, but on whether the data generated is regulator-ready, reproducible, and scientifically defensible . Yet not all Service Providers (formally known as Clinical Research Organizations (CROs)) bring the same level of expertise, infrastructure, or dedicated staff to ensure that outcome. Sponsors sometimes face a d

Oct 173 min read

The Advantages of Using U.S.-Based CROs for Study Data Collection

For medical device and wearable technology developers, the success of a clinical research study often hinges on one factor: the quality...

Oct 93 min read

From Prototype to Proof: How Parameters Research Laboratory Designs Validation Studies That Win Regulator Confidence

For medical device innovators, the leap from prototype to regulatory submission is filled with risk. Even a well-engineered product can...

Jul 242 min read