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FDA Clears Vasomedical Combined ECG Holter, Ambulatory Blood Pressure Monitoring System

Vasomedical, a provider of non-invasive treatment and management of cardiovascular diseases, has received FDA 510(k) clearance to market BIOX Model 2301 Combined ECG Holter and Ambulatory Blood Pressure Monitoring Recorder and Software Analysis System.

Vasomedical said that BIOX Model 1305 Holter Monitor and analysis software have received FDA clearance the previous year.

Derek Enlander, an NYC Internal Medicine physician, said: “The Vasomedical BIOX 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. 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.”

Jun Ma, president and CEO, said: “These are the first in a line of Vasomedical-BIOX ECG Holter and Ambulatory Blood Pressure Monitoring Systems that Vasomedical intends to bring to the marketplace. 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.

“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 therapy and patient management products, which include handheld EZ ECG and EZ 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.”

Vasomedical is primarily engaged in designing, manufacturing, marketing and supporting EECP external counterpulsation systems based on the company’s technology. EECP 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.