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CardioComm receives FDA clearance for OTC hand-held heart monitoring system
[January 24, 2012]

CardioComm receives FDA clearance for OTC hand-held heart monitoring system

Jan 24, 2012 (Datamonitor via COMTEX) -- CardioComm Solutions, Inc., a provider of ECG acquisition and management software solutions, has received the FDA clearance for over-the-counter, or OTC, sales and marketing of the company's consumer-based, hand-held heart rhythm monitor known as the HeartCheck pen handheld ECG.

The FDA clearance also included CardioComm Solutions' GEMS, or Global ECG Management System, Home software, which enables the HeartCheck Pen to be connected to a personal computer to upload the heart rhythm recording to CardioComm Solutions' C4 medical call service telemedicine group for review by a physician.

The HeartCheck Pen and GEMS Home solution provide an extension to the HeartCheck ECG Monitor solution, which may be used only under physician direction. Both devices can communicate with CardioComm Solution's C4 medical call center.

The HeartCheck Pen stores up to 20 ECGs, and its data can be downloaded to GEMS Home, where repeated recordings can be managed in a personal health data record. The GEMS Home software offers a simple software user interface for managing heart rhythm recordings and associated data.

"Through this consumer product," said Etienne Grima, CardioComm Solutions' CEO, "we are truly putting people's heart health into their own hands." The Pen will display only the heart rate count until an interaction with a physician occurs. Once a C4 physician has provided review and feedback to the customer, the Pen's screen can be unlocked to display the real-time ECG and heart rate count for subsequent heart rhythm recordings." Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon

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