Navigation Links
Signalife Receives FDA Clearance for OTC Non-Prescription Event Recorder Device
Date:11/26/2007

LOS ANGELES, Nov. 26 /PRNewswire-FirstCall/ -- Signalife, Inc. (Amex: SGN - News) 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.

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.


'/>"/>
SOURCE Signalife, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Signalife Provides Corporate Update
2. Legendary Earvin Magic Johnson Joins AFL/Signalife Cardiovascular Protection Team
3. Signalifes Dr. Harmison Launches Award-Winning Ambulatory Heart Monitor
4. Signalife Achieves $1.98 Million Sales Orders Thus Far
5. Signalife Receives Another $3.3 Million Sales Orders
6. NFL Hall of Fame Legend Fred Biletnikoff Joins AFL/Signalife Cardiovascular Protection Team
7. Signalife Continues to Procure Purchase Orders, Revenues
8. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
9. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
10. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
11. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... ... 04, 2016 , ... PBI-Gordon Corporation is pleased to announce Doug Obermann has ... his career at PBI-Gordon in February 1988, after finishing his masters in agronomy from ... from customer service to national product manager, to helping develop, name and launch many ...
(Date:5/3/2016)... , May 3, 2016 ... Chip (Genomics, Drug Discovery, Gene Expression) Lab-on-a-chip ... user (Academics Institutes, Diagnostics Centers), Fabrication Technology ... by MarketsandMarkets, the market is expected to ... USD 7.63 Billion in 2015, growing at ...
(Date:5/3/2016)... ... May 03, 2016 , ... In a list published by the Boston ... 76 fastest-growing private companies; a small percentage of the state's 615,000+ small businesses. The ... percent change in revenue from 2012 to 2015. , As this award ...
(Date:5/3/2016)... , ... May 03, 2016 , ... ... the addition of Dr. Nancy Gillett to its Board of Directors. Dr. Gillett ... served as Corporate Executive Vice President and Chief Scientific Officer. A board-certified veterinary ...
Breaking Biology Technology:
(Date:3/23/2016)... 23, 2016 ... Gesichts- und Stimmerkennung mit Passwörtern     ... MESG ), ein führender Anbieter digitaler ... mit SpeechPro zusammenarbeitet, um erstmals dessen Biometrietechnologie ... die Möglichkeit angeboten, im Rahmen mobiler Apps ...
(Date:3/22/2016)... PROVO and SANDY, Utah ... (NSO), which operates the highest sample volume laboratory in ... Tute Genomics and UNIConnect, leaders in clinical sequencing informatics ... the launch of a project to establish the informatics ... NSO has been contracted by the ...
(Date:3/18/2016)... 18, 2016 --> ... ICT, Manned & Unmanned Vehicles, Physical infrastructure and Perimeter Surveillance ... in the border security market and the continuing migration crisis ... Europe has led visiongain to publish this ... --> defence & security companies in the ...
Breaking Biology News(10 mins):