US Customers
The HeartTrends® software has FDA clearance.
FDA 510(k) Application Details - K012825
Indications for Use:
The HeartTrends® software is intended for the analysis, summary, and reporting of up to 3 channels of prerecorded ambulatory ECG data. It is also intended to provide measurements of the MPW (Multipole Parameter Weighted) HRV.
Device Description:
The HeartTrends® software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit, and assessment. It provides measurement of the MPW (Multipole Parameter Weighted) HRV. The HeartTrends® software is based on an algorithm which is constructed from the Multipole Method, based on a physical-mathematical description of complex time series. The Multipole Method generates several parameters, multipoles, where every single one of them describes the HRV.
Typical use of the Multipole Method in action as published in the American Journal of Cardiology:
Comparison of the Usefulness of Heart Rate Variability vs. Exercise Stress Testing for the Detection of Myocardial Ischemia in Patients Without Known Coronary Artery Disease. Goldkorn I, et al. Am. J. Cardiology (2015) 115:1518-1522.
Heart Rate Variability for Risk Assessment of Myocardial Ischemia in Patients Without Known Coronary Artery Disease: The HRV-DETECT Study. Goldenberg I, et al. J. Am. Heart Assoc. (2019) 8:e014540.
See Publications for more articles of usage.