Signalife Receives FDA Clearance For OTC Non-Prescription Event Recorder Device
Event Recorder Device
Signalife has received FDA 510(k) clearance to market and sell - without prescription - its ambulatory event recorder throughout the United States. This device, which Signalife will market as the Fidelity 200 HeartLife Tempo Card, is a direct-to-consumer non-prescription flexible credit card-sized heart monitoring device which will be used as an early-detection device by patients who desire to independently monitor their condition.
The HeartLife Tempo Card uses the award-winning amplification technology contained in Signalife's Fidelity 100 Heart Monitor. In operation, at the onset of an event that will be recorded, the patient will hold the event recorder to his/her chest, press the "record" button, and record up to a 45-second event. 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.
With the sensitivity of the amplification technology used in the Fidelity 200 HeartLife Tempo Card - developed by Signalife's Chief Technology Officer and renowned scientist Dr. Budimir Drakulic - the Company believes it will be able to allow patients to effectively monitor their hearts anytime, anyplace, without the necessity of a prescription or other physician intervention. This, in turn, will lead to additional care and may lead to earlier intervention and other preventative measures for cardiovascular disease - the most costly of all diseases nationwide with annual expenditures approaching $400,000,000 spent across the country.
Dr. Lowell Harmison - the Company's CEO and former official for the United States in various regulatory health care capacities, including Principal Deputy Assistant Secretary for Health of the U.S. Public Health Service, Department of Health and Human Services, commented: "I am gratified at the work of Dr. Drakulic and Signalife's Director of Regulatory Affairs, Bill Matthews, in bringing this dream to fruition. I have always talked about a 'level playing field,' which doesn't exist when patients have no ability to see the early warning signs and other signals of cardiovascular disease. It is one thing to be symptomatic. And it is quite another to learn about the warning signs when the symptoms are silent. The Fidelity 200 HeartLife Tempo Card is the beginning of that "sea change" in care that I have been referring to, when early detection can actually be realized. I believe the motto that Signalife has adopted for the HeartLife Tempo Card will be borne out by the use of this device - "it is better to have your HeartLife Card when you need it, than to need it and not have it'."
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.