FDA clears Boston's heart rate variability test:
This article was originally published in Clinica
Executive Summary
Boston Medical Technologies has received US FDA 510(k) clearance to expand the use of its heart rate variability test to detect autonomic nervous system dysfunction, a condition prevalent in patients with chronic diseases, such as diabetes. The Anscore health management system, which assesses and documents a patient's heart rate variability in response to paced respiration and other controlled exercises, was originally cleared for heart rate variability testing in 1999, said the Wakefield, Massachusetts company.