On September 16, 2025, the FDA issued a safety communication warning consumers and healthcare providers about the risks of using unauthorized devices that claim to blood pressure, including certain smartwatch and smart ring features. The agency emphasized that devices without FDA marketing authorization have not been evaluated for safety or effectiveness—leaving users vulnerable to inaccurate readings and potentially harmful health decisions. While this warning highlights t

At Parameters Research Laboratory (PRL) , we specialize in providing regulatory-grade validation for blood pressure monitoring devices, including both traditional cuff-based devices and emerging cuffless wearables. As a dedicated blood pressure validation testing lab , we deliver the scientific rigor and regulatory alignment developers need to succeed in FDA and CE mark submissions. Why Blood Pressure Validation Matters Accuracy in blood pressure monitoring is critical