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510(k) for Zymed's ischemia analysis programme and home-use cardiac event recorder:

This article was originally published in Clinica

Executive Summary

Zymed has received 510(k) clearance from the US FDA for its ST/ischaemia analysis program and its HomeTrak Plus cardiac event recorder. The software, designed to be incorporated in Zymed's EASI 12 Lead electrocardiogram technology, monitors and analyses changes to the diagnostic ST segment of an ECG, allowing doctors to act quickly when an ischaemic episode is identified. The HomeTrak Plus device records transient ECG events in ambulatory cardiac patients. At the press of a button, the beeper-sized product stores information of a cardiac event the patient is experiencing. This is then transmitted down a telephone line to a receiving station and analysed. The Camarillo, California-based company believes HomeTrak Plus will be prescribed for use up to 30 days.

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