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CardioNet Arrhythmia Detector Receives 510k

December 11th, 2006 |  Published in Uncategorized

CardioNet

CardioNet appears to be moving beyond high tech holter monitoring and into ambulatory cardiac monitoring. The new device has be ability to do arrhythmia detection in the sensor (rather than the PDA-like monitor) and transmitting alarms to CardioNet's Monitoring Center that provides 24×7 analysis of alarms and related cardiac rhythms.

The last two pages of the FDA approval document (pdf file) list 8 outpatient cardiac monitoring indications for use. The document also describes, “[d]ata from the device may be used by another device to analyze, measure or report QT interval.” This sounds like export to an ECG cart.

Pictured right is the old CardioNet device, shot at the Healthcare Unbound conference this past summer.

About the author

Gee

After almost 25 years in health care Tim remains with his first love, connectology, the automation of workflow through the integration of medical devices with information systems.


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