OTC Heart Monitor Cleared
A new, small heart monitoring device received FDA approval for over the counter use, patients may buy the Signalife, Incorporated device without a prescription from their physician. Signalife issued a press release about device approval.
The Fidelity 200 HeartLife Tempo Card is about the size of a credit card. The tool is an ambulatory event recorder that uses electrocardiography monitoring. The Fidelity 200 includes amplification used in the company’s flagship Fidelity 100 product, which has well documented sensitivity to monitor heart activity.
When patients detect a cardiac event, they hold the monitor to their chest and record the episode. Data can be recorded for up to 45 seconds, with a storage capability for six events. Patients can then either take the recorder for information review by their physician or submit their data to a 24 hour monitoring center to be read.
The device is intended for patients who want to monitor their health condition on their own as an early detection tool. Signalife suggests that this tool will facilitate active involvement by patients in their care. Cardiac disease is the primary cause of mortality across the United States. Use of this ECG monitoring device can facilitate early intervention, reducing costs to treat these conditions and improve patient outcomes.
The final model for marketing and sales has yet to be approved by the FDA. Signalife speculates that the device will be ready for marketing during the first quarter of 2008.
November 30, 2007 Related topics: Product Approval & Certification, Cardiology