Cuffless Blood Pressure Monitoring – Not for the Faint-of-Heart (Pun Intended)

This article will summarize these challenges and also provide optimism for the refreshingly near future. Namely, while the progress towards FDA-cleared cuffless BP monitoring may feel protracted, significant technological advances, regulatory modernization, and clinical use case validation are rapidly advancing and aligning.  Key Challenges Confronting OTC Cuffless Blood Pressure Monitoring Scientific Risks At the most fundamental level, the jury’s still out on whether sufficiently accurate noninvasive, cuffless, calibration-free blood pressure monitoring is physically realizable at all. Namely, “Do the laws of nature even allow for this?” This scientific risk is bolstered by the fact that, at least as of the date of this article’s publication, there have been no peer-reviewed independent clinical studies proving that any such technology can definitively meet the critical performance targets required by the current regulatory “gold standard” — ISO 81060-2:2018 [26]. At the heart of scientific risks is that cuffless BP monitoring solutions intrinsically do not directly measure blood pressure but rather measure proxies for BP. For example, devices employing pulse transit time (PTT) focus on accurately measuring the time it takes a pulse wave from the heart to reach the measurement site (such as an extremity). Typically an ECG sensor is used to mark the time when the heart starts beating, and a PPG sensor is used to mark the time when the pulse wave reaches th...
Source: EMR and HIPAA - Category: Information Technology Authors: Tags: Clinical Communication and Patient Experience Health IT Company Healthcare IT Hospital - Health System Telemedicine and Remote Monitoring AliveCor Blood Pressure Blood Pressure Cuffs Blood Pressure Monitoring BP Calibration-Free Bloo Source Type: blogs