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news.Signalife has received FDA 510(k) clearance to market and sell without prescription its ambulatory event recorder throughout the US. This device, which Signalife plans to market as the Fidelity 200 HeartLife Tempo Card, is a direct-to-consumer, non-prescription, flexible, credit card-sized heart monitoring device that will be used as an early-detection device by patients who desire to independently monitor their condition.
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The HeartLife Tempo Card uses the amplification technology contained in Signalife’s Fidelity 100 Heart Monitor and will be capable of storing up to six, 45-second recordings. With the sensitivity of the amplification technology used in the Fidelity 200 HeartLife Tempo Card, the company believes that it will be able to allow patients to effectively monitor their hearts anytime, anyplace, without the necessity of a prescription or other physician intervention.
The FDA requires various fabrication and testing methodologies to be followed as the device moves into the marketplace. The company is poised to quickly achieve these objectives, and anticipates that a final production model of the Fidelity 200 HeartLife Tempo Card will be introduced into the market in the first quarter of 2008.