Healthcare Industry News:  cardiac monitor 

Devices Monitoring FDA

 News Release - April 6, 2009

Vasomedical Introduces BIOX Holter Monitoring Systems and Analysis Software

WESTBURY, N.Y.--(HSMN NewsFeed)--Vasomedical, Inc. ("Vasomedical") (OTC: VASO ), a leader in the noninvasive treatment and management of cardiovascular diseases, today announced that it has received FDA 510k 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 Marking certification to market in the EU countries, is a compact, lightweight, 3-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.

“As a prominent problem in the developed nations, the diagnosis of heart diseases is expensive and time consuming. Shifting some of this diagnostic workup from hospital facilities to an outpatient or doctor’s office can relieve some of the burden and expense. In this context Holter monitoring systems can provide an invaluable service. The recorded data not only can be utilized in the early detection of cardiac abnormalities but also in monitoring the post treatment phase of drug therapy or EECP® therapy and in post operative cardiac surgery,” commented Derek Enlander, MD, a director of Vasomedical. “The introduction of Vasomedical-BIOX ambulatory products is an important step towards providing comprehensive non-invasive medical devices for cardiac care. Vasomedical has selected this series of products after rigorous research and testing, which are smaller in configuration and give the patient less inconvenience during the 24 hours or more of monitoring. In addition, the reliability of the Vasomedical-BIOX Holter monitor has been shown to be high. It will be less expensive than comparable monitors presently on the market.”

“With an aging baby boomer generation and changes in diet and lifestyle, there’s an increased need for cardiac monitoring and early diagnosis of cardiovascular diseases. According to some industry forecasts, the Holter monitoring systems market is to grow to over $140 million by 2010,” commented Jun Ma, president and CEO. “Vasomedical is committed to improving patients’ lives with non-invasive medicine. We are pleased to offer the Model 1305 as well as the CB series software at an affordable price to help physicians provide their patients with the best possible care. As this is our first product diversification from the EECP therapy systems, we will continue to grow the company and plan to introduce other products that provide synergy with our existing product offerings, including additional portable and ambulatory patient monitoring and recording devices.”

About Vasomedical, Inc.

Vasomedical, Inc. is the market leader in EECP® (enhanced external counterpulsation) devices and services for the non-invasive treatment of cardiovascular diseases. EECP therapy serves to increase circulation in areas of the heart with less than adequate blood supply and improve systemic vascular function, including improved endothelial cell function. Vasomedical is expanding into the non-invasive diagnostic field by introducing new products including the Holter monitors. Holter devices monitor and record a patient’s cardiac rhythm; the data generated from the Holter monitor is then analyzed and utilized in the early detection of cardiac abnormalities such as ischemia. For more information please visit

About BIOX Instruments Co., Ltd.

BIOX Instruments Co., Ltd., based in China, is a strategic partner of Vasomedical. Established in 1993, BIOX conducts research, designs, manufactures, markets and services electrical medical instruments. The core products of BIOX include Holter recorders, ambulatory blood pressure monitors with BIOX proprietary technology and comprehensive analysis software.

Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this report, words such as “anticipated,” “believes,” “could,” “estimates,” “expects,” “may,” “offers,” “plans,” “potential,” and “intends” and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to update forward-looking statements as a result of future events or developments.

Source: Vasomedical

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