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VivaQuant, LLC announces U.S. FDA filing acceptance of 510(k) premarket notification for its HS-1 Rhythm ExpressTM Interval and Arrhythmia Analysis Software

HS-1 Rhythm Express Software designed to achieve fast, efficient, and accurate analysis of ambulatory ECGs is under FDA review

February 2017

St. Paul, MN -- VivaQuant, LLC is proud to announce that the U.S. Food and Drug Administration (FDA) has accepted for review its 510(k) premarket notification for the HS-1 Rhythm Express Interval and Arrhythmia Analysis Software. The HS-1 Software leverages VivaQuant's proprietary noise-tolerant MultiDomain Signal Processing (MDSPTM) technology to increase arrhythmia detection accuracy, reduce interval measurement variability, and improve ECG readability. "The FDA acceptance of our premarket notification is an important milestone and brings us closer to offering an efficient, accurate, and streamlined solution for evaluation of electrocardiograms from ambulatory patients," said Marina Brockway, PhD, VivaQuant founder and Chief Technology Officer. "Extracting accurate information efficiently from ambulatory ECGs has always been challenging because of the noise that is often present in these recordings. We are optimistic our MDSP technology will offer patients and physicians the same efficiency, speed, and report quality improvements that we have observed in our experience with analysis of thousands of ECG recordings in our research services business."

About VivaQuant, LLC

VivaQuant provides hardware, software and embedded algorithms for processing ECGs as well as ECG data analysis services. Its Multi-Domain Signal Processing (MDSPTM) technology has been shown to remove 95% of noise from ambulatory ECGs while preserving fidelity, significantly reduce analysis and reporting labor, and greatly improve the accuracy of information extracted for diagnostic and cardiac safety purposes. The AE-1010 software has not been approved by the FDA or any other regulatory body for use in diagnosing or treating a disease.

For additional information visit www.VivaQuant.com, call (651) 383-2315, or email mdsp_info@vivaquant.com.

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