Signalife Submits Credit-Card Sized Cardiac Event Recorder for FDA Review
May 7, 2007 — Signalife Inc. 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.
Utilizing its proprietary signal processing technology and amplification process, Signalife says the exceptional signal clarity of the 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.
For more information visit www.signalife.com.