Why ISO 81060-2 Matters for Accurate Blood Pressure Monitoring   Non-invasive blood pressure devices must demonstrate dependable performance before developers can advance toward FDA or CE mark submissions. ISO 81060-2  “Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type ” sets a clear bar for clinical validation—defining study methods, reference comparisons, subject distribution, cuff/arm-size coverage, and prespecified

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: The Importance of Clarity in Blood Pressure Device and Software Classification   As wearable technology advances, more devices are integrating blood pressure features—from clinical-grade monitors to smartwatches that “notify” users of potential changes. But not all blood pressure devices are created—or regulated—the same.  Understanding the difference between a blood pressure measurement device (FDA product code DXN) and a hypertension machine learning-based no

Why Verification Matters in BP Devices   Blood pressure (BP) measurement is a foundation of cardiovascular care. But not all BP devices are created equal — increasingly, clinicians and patients recognize that a blood pressure reading is only useful if it’s accurate.  To address market confusion around which BP monitors are reliable, the American Medical Association (AMA) introduced the Validated Device Listing (VDL) . The VDL is a free resource that helps clinicians, health

On September 16, 2025, the FDA issued a safety communication  warning consumers and healthcare providers about the risks of using...

A recent JAMA survey  revealed that many U.S. adults lack key knowledge about hypertension, including the correct threshold for diagnosis...

At Parameters Research Laboratory (PRL) , we specialize in providing regulatory-grade validation for blood pressure monitoring devices,...

Blood Pressure Monitoring: A Clinical Cornerstone   Blood pressure measurement is one of the most common clinical assessments, shaping...

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

When it comes to blood pressure validation studies , accuracy is not optional—it’s the foundation. At Parameters Research Laboratory ...

The evolution of blood pressure monitoring is entering a new era—one where cuffs may no longer be required. Cuffless blood pressure...

Wearable medical technology is reshaping diagnostics, monitoring, and chronic disease management. But clinical trials for wearables face...

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

The European market represents a major opportunity for developers of blood pressure (BP) monitoring technology, but with great...

Introduction The emergence of cuffless blood pressure (BP) monitors has opened new frontiers in cardiovascular and metabolic health...