Vicor's heart testing algorithm receives FDA clearance
This article was originally published in Clinica
The PD2i nonlinear algorithm, software developed by Vicor Technologies (Boca Raton, Florida) to aid heart monitoring, has gained US 510(k) clearance. Used with the PD2i Analyzer, the algorithm allows measurement of heart rate variability at rest, and in response to controlled exercise and paced respiration in patients undergoing cardiovascular disease testing. This approval enables Vicor to sell the PD2i Analyzer directly to cardiologists as a diagnostic specifically for use in cardiovascular disease testing. The device is also in trials for monitoring patients with concussion (www.clinica.co.uk, 27 October 2010) and diabetic neuropathy (www.clinica.co.uk, 31 January 2011).
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