Physiological monitoring in wearables has expanded rapidly, but blood pressure and heart-rate sensing now represent two of the most scrutinized technologies for regulators. As devices transition from lifestyle tools to clinical-grade solutions, development teams must demonstrate performance that meets rigorous standards such as ISO 81060-2 , ISO 81060-7, ISO 81060-3 and ISO 14155 .  Parameters Research Laboratory (PRL) supports developers navigating this shift by delivering

A Familiar Framework with Important Regulatory Implications   In January 2026, the FDA released a draft guidance titled “ Cuffless Non-Invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation .” The document outlines FDA’s current recommendations on how cuffless blood pressure (BP) devices—both intermittent and continuous—should be clinically evaluated to support premarket submissions.  For developers already working in this space, the guidance

When planning a clinical research study intended to support an FDA submission , sponsors often encounter terms such as multi-site, multi-investigator , and single-site, multiple-location . While these models may appear operationally similar, they differ in oversight structure, execution, and how evidence is evaluated by the FDA—particularly for cuffless blood pressure devices . Understanding these distinctions is essential for aligning trial design with FDA expectations and w

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

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...

Setting the Standard in Clinical Research   Medical device and wearable technology developers face increasing demands for...

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

Introduction   Cuffless blood pressure (BP) monitoring has become a major focus in wearable and medical device innovation. Unlike...

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