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Electrocardiograms

Resting electrocardiogram approved for sale in the U.S.

Published in Medical Letter on the CDC and FDA, November 16th, 2003

Del Mar Reynolds Medical, Inc., has received regulatory approval for the sales and marketing of its new interpretative 12-lead PC-ECG systems: CardioDirect12 i/m and their mobile 12-lead system CardioCollect12 i/m.

"The regulatory clearance of the interpretation and measurement algorithms clears the way for us to bring our proven resting electrocardiogram (ECG) product line into the U.S. market. Our personal computer (PC)-based and mobile hand-held 12-lead ECG devices are widely used in Europe and we have been waiting for this moment since the merger of Del Mar Medical with Reynolds Medical in January," said Raphael Henkin, PhD, president of Del Mar Reynolds Medical,...

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