GREENVILLE, S.C., July 2 /PRNewswire-FirstCall/ -- Signalife, Inc. (“Company”), 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.
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, client 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. Additional risks are found in clientele acceptance of Signalife’s product-set. 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, but are significant and should be carefully evaluated by any and all investors.
Signalife, Inc.
CONTACT: Kevin Kading for Signalife, Inc., +1-212-918-4606
Web site: http://www.signalife.com/
