LOS ANGELES Signalife on Monday received Food and Drug Administration 510(k) clearance to market and sell without a prescription its ambulatory event recorder.
The device, which Signalife will market as the Fidelity 200 HeartLife Tempo Card, is a flexible, credit-card-sized heart monitoring device that can be used as an early-detection system by patients who desire to independently monitor their heart health.
The card will enable the patient to measure cardiovascular activity during exercise or other everyday activities by holding the event recorder to his/her chest, pressing the “record” button, and recording up to a 45-second event.
The recordings may increase the ability to detect silent ischemia or other difficult to detect abnormalities of the heart.
The event recorder will be capable of storing up to six, 45-second recordings. The patient will then either take the recorder to his or her physician for review, or transmit the data to a subscription-based 24-hour monitoring center where it can be immediately evaluated by a qualified ECG technician, cardiac nurse or cardiologist.
The company 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.