Vasomedical Receives FDA 510(k) Clearance on Two New Devices
Significantly Expands the Company’s Ambulatory Monitoring Product Line
Press Release Source: Vasomedical, Inc. On Wednesday June 29, 2011, 4:11 pm EDT
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 non-invasive treatment and management of cardiovascular diseases, today announced its receipt of U.S. FDA 510(k) clearance to market its Vasomedical-BIOX™ Model 2302 Combined 12-Channel ECG Holter/Ambulatory Blood Pressure Monitor and Model 1804 Ambulatory Blood Pressure Monitor. These new models complement the Company’s already cleared Model 1305 3-Channel ECG Holter Monitor and Model 2301 Combined 3-Channel ECG Holter/Ambulatory Blood Pressure Monitor, and significantly expand its offering of BIOX series ambulatory patient monitoring products in the U.S. market under its exclusive North American Distributorship Agreement with BIOX Instruments Co., Ltd. based in Wuxi, China.
With the new clearance by the U.S. FDA, Vasomedical now offers both 3-channel (Model 2301) and 12-channel (Model 2302) Combined Holter ECG/ABP Monitors. While they can also be configured by the user to record ECG or blood pressure data only, the newly cleared Model 1804 and the previously cleared Model 1305 provide economic alternatives for applications where only blood pressure or ECG recording is needed. All Vasomedical-BIOX™ series monitors work with the CB Series Analysis Software, also previously cleared by the U.S. FDA, for data scanning, analysis and reporting.
Reliable and comprehensive patient information is crucial to early diagnosis and therefore successful treatment of cardiovascular diseases, which continue to increase in occurrences in the population worldwide. The collection and analysis of multi-parameter data, with full disclosure consisting of 12-lead ECG and simultaneous blood pressure measurement, provide valuable physiological information the physician needs to more accurately identify cardiac irregularities and assess the effect of a specific course of treatment. The lightweight, versatile Vasomedical-BIOX™ Model 2301 and 2302 monitors are designed to address such a growing need and are believed to be the only U.S. FDA cleared devices of its type in the world.
Vasomedical is dedicated to the worldwide marketing of medical products for better patient management. The new FDA clearance again demonstrates the Company’s continued commitment to providing innovative solutions to improve quality of life,” commented Dr. Jun Ma, President and CEO of Vasomedical. “Vasomedical is dedicated to delivering products that improve patient care and reduce healthcare costs. These and other new product offerings along with our core, proprietary Enhanced External Counterpulsation (EECP®) therapy systems provide patients, physicians and payers solutions to meet the challenges of delivering cost-effective healthcare.”
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 www.vasomedical.com.