Heart Tronics Inc (HRTT)

[TechKim]

FDA Certifies Signalife Fidelity 100 ECG Monitor System for Export to Mexico
Monday July 2, 9:15 am ET


GREENVILLE, S.C., July 2 /PRNewswire-FirstCall/ -- Signalife, Inc. ("Company"), (Amex: SGN - News) announced today that it has received a Certificate to Foreign Government which allows the importation of the Signalife Fidelity 100 ECG Monitor System into Mexico certifying that a firm and its devices are in compliance with U.S. law. The certification states that the Fidelity 100 may be marketed in, and legally exported from the United States to Mexico as the manufacturing plant is considered to be in substantial compliance with current Good Manufacturing Practices, the product is properly registered and listed, 510(k) cleared and meets all labeling requirements.


"This is an important milestone for the company as there has been interest in markets outside the US for a product that offers both clinical advantages for the healthcare community, but also has applications in the wellness industry. Now we are poised to sell units in this market that has waited patiently for this approval," states Bill Matthews, Signalife's Director of Regulatory Affairs.

About Signalife, Inc.

Signalife, Inc. engages in the research, development, and marketing of signal-monitoring devices for detecting diseases. It primarily offers patient modules that are used as part of a heart monitor system to acquire, amplify, and process physiological signals associated with a patient's cardiovascular system. Signalife is based in Greenville, South Carolina. For more information visit http://www.signalife.com.