Vasomedical Receives FDA 510(k) Clearance on Two Additional BIOX™ Monitors
Now Offering a Complete Line of Ambulatory Monitoring Products
WESTBURY, N.Y.--(BUSINESS WIRE)-- Vasomedical, Inc. (“Vasomedical”) (OTC:VASO.PK.ob - News), a leader in the sale of diagnostic imaging products through its wholly-owned subsidiary, VasoHealthcare, as well as a leader in the technology for non-invasive treatment and management of cardiovascular diseases, today announced its receipt of the U.S. FDA 510(k) clearance to market its Vasomedical-BIOX™ Model 1303 3-channel ECG Holter Monitor and Model 1304 12-channel ECG Holter Monitor. These new BIOX™ models, together with the Company’s already FDA cleared Model 1305 3-channel ECG Holter Monitor, Model 1804 Ambulatory Blood Pressure Monitor and 2300 Series Combined ECG Holter/Ambulatory Blood Pressure Monitors, form a complete line of ambulatory monitoring products for long term recording and analysis of ECG and blood pressure data, offering flexible solutions to clinicians for various diagnostic needs. All Vasomedical-BIOX™ series monitors work with the CB Series Analysis Software, also previously cleared by the U.S.FDA.
Ambulatory ECG and blood pressure data provide important information about incidental cardiovascular abnormalities that are often not observable during a visit to the physician’s office, and are therefore extremely valuable for early diagnosis of the ever increasing cardiovascular diseases. Vasomedical’s BIOX™ brand ambulatory monitoring products, including the 1300 Series ECG Holter monitors, 1800 Series ambulatory BP monitors and 2300 Series combined ECG Holter/ABP monitors, are easy for clinicians to use, comfortable for patients to carry, and are all priced competitively. The newly cleared ultra compact Model 1303 ECG Holter Monitor is among the world’s smallest and lightest, with an LCD display for real time viewing of recorded information.
“It is an exciting development that we received U.S. FDA clearances of four BIOX™ series products within a week,” commented Dr. Jun Ma, President and CEO of Vasomedical. “We are achieving our goal of building a portfolio of complementary products to address the growing needs of the medical market. Together with its core technology of Enhanced External Counterpulsation (EECP®) therapy systems, the Company has strategically positioned itself for growth as a full solutions partner to the global cardiac marketplace that demands the best in products, technology, support and innovation.” Vasomedical will exhibit all BIOX™ series products and the Lumenair EECP® system at the upcoming Florida International Medical Expo (FIME) in Miami Beach, Florida, August 10-12, 2011, the European Society of Cardiology (ESC) Congress in Paris, France, August 27-30, 2011, as well other major global events, including those sponsored by the American College of Cardiology (ACC), American Heart Association (AHA), American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and theHeart Failure Society of America (HFSA).
Vasomedical, Inc. is engaged in designing, manufacturing, marketing and supporting EECP® external counterpulsation systems based on the Company's proprietary technology. EECP® therapy is a non-invasive, outpatient therapy for the treatment of cardiovascular diseases and is currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The Company provides hospitals, clinics and private practices with EECP® equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes. The Company also provides other noninvasive medical equipment including Holter monitors and ambulatory blood pressure monitors.
Vaso Diagnostics d/b/a VasoHealthcare, a wholly owned subsidiary of Vasomedical, Inc., is a professional sales representation organization offering vendors of medical devices an alternative third party sales channel. Through an agreement with GE Healthcare, it is currently engaged as an exclusive sales representative for certain GE Healthcare products.
Additional information is available on the Company's website at http://www.vasomedical.com
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 “anticipates”, “believes”, “could”, “estimates”, “expects”, “may”, “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 following: the effect of business and economic conditions; the effect of the dramatic changes taking place in the healthcare environment; the impact of competitive procedures and products and their pricing; medical insurance reimbursement policies; unexpected manufacturing or supplier problems; unforeseen difficulties and delays in the conduct of clinical trials and other product development programs; the actions of regulatory authorities and third-party payers in the United States and overseas; uncertainties about the acceptance of a novel therapeutic modality by the medical community; continuation of the GEHC agreement; and 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.
Investor Relations:Vasomedical, Inc.
Dr. Jun Ma, 516-997-4600 President and CEO