Vasomedical Announces FDA 510(k) Clearance on the First Combined ECG Holter and Ambulatory Blood Pressure Monitoring System
Apr 9, 2010 11:27:00 AM
Copyright Business Wire 2010
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WESTBURY, N.Y.--(BUSINESS WIRE)-- Vasomedical, Inc. ("Vasomedical") (OTC: VASO.OB), a leader in the non-invasive treatment and management of cardiovascular diseases, today announced the receipt of the US FDA 510(k) clearance on April 2, 2010 to market its Vasomedical-BIOX(TM) Model 2301 Combined ECG Holter and Ambulatory Blood Pressure Monitoring Recorder and Software Analysis System. Last year, the Vasomedical BIOX(TM) Model 1305 Holter Monitor and analysis software received FDA clearance.
Dr. Derek Enlander, an NYC Internal Medicine physician commented that "The Vasomedical BIOX(TM) 2301 is the only personal combined system to simultaneously and continuously record and store EKG and blood pressure data for 24 hours. The ability to view these parameters simultaneously, side by side is unique," continued Dr. Enlander, "it gives the physician more useful information to evaluate the patient's cardiovascular status and make appropriate clinical judgment. Over the past few years, Holter monitors and other ambulatory devices have increased in use, allowing early diagnosis and disease management not only by cardiologists but by general practitioners. I believe this product will have a great impact on the improvement of healthcare quality and reduction of healthcare cost."
"These are the first in a line of Vasomedical-BIOX(TM) ECG Holter and Ambulatory Blood Pressure Monitoring Systems that Vasomedical intends to bring to the marketplace," said Dr. Jun Ma, President and CEO, who further stated that "the introduction of Model 1305 Holter Monitor last year placed Vasomedical into the patient monitoring business with a high quality digital equipment that has enjoyed international success. The Model 2301, however, will make Vasomedical a supplier of ambulatory equipment, because it is so far the only combined ambulatory ECG/blood pressure recording device in the United States. In addition to being a compact device that replaces two separate recorders, it also provides interactive blood pressure recording at times of certain cardiac abnormalities, thus significantly enhancing the diagnostic value of the recorded data while increasing patient comfort and ease of use. Along with our core EECP(R) therapy and patient management products, which include handheld EZ(TM) ECG and EZ(TM) O2 pulse oximeters, Vasomedical continues to expand its presence in the marketplace with innovative and noninvasive products designed to improve patient care and reduce healthcare costs."
About Vasomedical
Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP(R) external counterpulsation systems based on the Company's proprietary technology. EECP(R) therapy is a non-invasive, outpatient therapy for the treatment of diseases of the cardiovascular system currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function. The Company provides hospitals, clinics and private practices with EECP(R) equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes. EECP(R) is a registered trademark for Vasomedical's enhanced external counterpulsation system. Additional information is available on the Company's website at www.vasomedical.com.
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 release, words such as "anticipate", "believes", "estimate", "expect", "should", "intend", "projects", "objective" and "appears" 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 following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments
Source: Vasomedical, Inc.
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Vasomedical
Inc.
Dr. Jun Ma
President and CEO
516-997-4600
or
David Singh
CFO
516-997-4600
or
Investor Relations:
customerservice@vasomedical.com
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