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Viz HCM is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG made on compatible ECG devices. Viz HCM is capable of analyzing the ECG, detecting signs associated with hypertrophic cardiomyopathy (HCM), and allowing the user to view the ECG and analysis results. Viz HCM is indicated for use on 12-lead ECG recordings collected from patients 18 years of age or older. Viz HCM is not intended for use on patients with implanted pacemakers. Viz HCM is limited to analysis of ECG data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis. Viz HCM identifies patients for further HCM follow-up and does not replace the current standard of care methods for diagnosis of HCM. The results of the device are not intended to rule-out HCM follow-up.

The Viz HCM ECG Analysis Algorithm (HCM Algorithm) is a machine learning-based software algorithm that analyzes 12-lead electrocardiograms (ECGs) for characteristics suggestive of hypertrophic cardiomyopathy (HCM). The mobile software module enables the end user to receive and toggle notifications for ECGs determined by the Viz HCM ECG Analysis Algorithm to contain signs suggestive of HCM. The Viz HCM is a Software as a Medical Device (SaMD) intended to analyze ECG signals collected as part of a routine clinical assessment, independently and in parallel to the standard of care. Viz HCM is a combination of software modules that consists of an ECG analysis software algorithm and mobile application software module.