ECG Monitor Checks Mobile Patients

A new electrocardiograph (ECG) monitoring system can detect and quantify transient ischemic episodes in mobile patients and will provide clinical real-time vital heart information.

The Fidelity 100 ambulatory monitor, manufactured by Signalife (Greenville, SC, USA), is a 12-lead ECG monitor that allows the recording of a high-quality ECG signal from cardiac patients who are walking. The technology can also record small bioelectrical signals and amplify them without amplifying background noise, and this should lead to major advancements in the diagnosis and prevention of heart disease. The system has been approved by the U.S. Food and Drug Administration (FDA).

The device Implementation, Validation, and Application (DIVA) program for the Fidelity monitor has been completed at Duke University (Durham, NC, USA). A total of 108 patients, with clinical indications for elective or possible percutaneous coronary intervention (PCI), were recorded to provide detailed documentation of the device's ability to detect and quantify transient ischemic episodes in comparison to conventional ECG devices. The data are currently being analyzed by the eECG Core Laboratory at the Duke Clinical Research Institute (DCRI).

"The successful completion of the Duke University DIVA study is a significant milestone for the company,” said Pamela Bunes, president and CEO of Signalife. "The DIVA study, along with new clinical studies that we plan to initiate at the Cleveland Clinic, will definitely demonstrate that previously un-captured data about the heart will now be available for use by the entire cardiology community. We are confident that revolutionary state-of-the-art products will allow for improved patient monitoring before, during, and following cardiac procedures.”



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Signalife
Duke University