April 10, 2009 - Vasomedical Inc. this week said it received FDA 510(k) clearance to market Vasomedical-BIOX 1305 ECG Holter Monitor and CB Series Ambulatory ECG Analysis Software.
The Vasomedical-BIOX 1305 Holter Monitor is the latest addition to Vasomedical’s product line. The Model 1305, which has already received CE mark certification in the EU countries, is a compact, lightweight, three-channel ECG Holter monitor designed for monitoring a patient's cardiac rhythm for 24 to 72 hours and recording ECG on a standard SD memory card. It features a high signal sampling rate and high-resolution digital recording for comprehensive data analysis. The data recorded on the 1305 monitor is utilized in the early detection of cardiac abnormalities such as ischemia and arrhythmia.
Data recorded by the Model 1305 can be quickly analyzed using the proprietary Vasomedical-BIOX CB Series Analysis Software. The CB series software provides clear, quick, and accurate recognition of QRS complexes and classification; a proprietary two-tier automatic classification process for “suspicious” waveforms; comprehensive event reports and ST-segment reports; and many other data viewing, analysis, and reporting capabilities.
For more information: www.vasomedical.com