Heart Tronics Inc (HRTT)

[TechKim]

Signalife Submits Fidelity 200 Cardiac Event Recorder Pre-Market Notification to FDA
Thursday May 3, 9:04 am ET


GREENVILLE, S.C., May 3 /PRNewswire-FirstCall/ -- Signalife, Inc. (Amex: SGN - News) has announced that it has submitted its Fidelity 200 Cardiac Event Recorder 510K pre-market notification to the FDA. Upon clearance the recorder will be sold over-the-counter.


There is no widely accepted over-the-counter product on the market today. Utilizing the Company's proprietary signal processing technology and amplification process, the exceptional signal clarity of this device will allow it to become a new standard in cardiac event recording.

Other significant benefits of the Fidelity 200 include its credit card size and ease of use where a user simply places it on their chest and following three easy steps records and transmits their ECG to the monitoring center. The Fidelity 200 is user friendly to individuals concerned about their current health risks and individuals who have the desire for long term ECG monitoring. Signalife believes that this product will consolidate and create a new market that addresses not only the event monitor market but the wellness market as well, by providing individuals information about their heart health prior to the onset of cardiovascular disease.

It is thought that this recorder will provide patients with an additional possibility to monitor their heart when they are no longer eligible for Medicare-reimbursed event recorders. Through an educational program developed to assist physicians in understanding the benefit of this device to their practice and patients, the Fidelity 200 will be presented as a product that physicians can recommend to their patients.

Users will identify their physician during the enrollment process to the monitoring service. This will allow any irregular ECG results obtained by the monitoring center to be reviewed by the physician who will provide a diagnosis to the patient.

"We are pleased to offer a new product that will provide consumers with the same sophisticated technology used by hospitals and physicians, that allows the patient to make informed decisions regarding their cardiac health when the reimbursement for existing products may not apply," states Pamela Bunes, company CEO.

About Signalife

Signalife, Inc. is a life sciences company focused on the monitoring and detection of disease through continuous biomedical signal monitoring. Signalife uses its patented signal technology to design and develop medical devices that simplify and reduce the costs of diagnostic testing and patient monitoring in an ambulatory setting.

Signalife is publicly traded on the American Stock Exchange under the symbol SGN. The website for the company is http://www.Signalife.com. Clear Data. Trusted Results.

Caution Regarding Forward-Looking Statements

Statements in this release that are not strictly historical are "forward- looking" statements. Forward-looking statements involve known and unknown risks, which may cause Signalife's actual results in the future to differ materially from expected results. Factors which could cause or contribute to such differences include, but are not limited to, failure to complete the development and introduction of heart monitoring and other biomedical devices incorporating Signalife's technology, failure to obtain federal or state regulatory approvals governing heart monitoring and other biomedical devices incorporating Signalife's technology, inability to obtain physician, patient or insurance acceptance of for heart monitoring and other biomedical incorporating Signalife's technology, and the unavailability of financing to complete management's plans and objectives, including the development of heart monitoring and other biomedical incorporating Signalife's technology. These risks are qualified in their entirety by cautionary language and risk factors set forth and to be further described in Signalife's filings with the Securities and Exchange Commission.




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Source: Signalife, Inc.