Vasomedical Combined ECG Holter, Ambulatory Blood Pressure/Software Monitoring System Approved by the FDA
Posted Apr 12 2010 9:44am
ECG or EKGs as sometimes called are getting quite sophisticated. Vasomedical has primarily been focused towards the cardiology area but with some of the new product lines and electronic monitoring, plan to bring this level to the primary care area too. Doctors are certainly going to be very busy people with monitoring information provided by devices if they are not already using some type of software/device system.
Our hearts are going to be so well analyzed in a few years and expect more devices of this type to hit the market as well. The next question is “do we want to know” and “can we afford it, and will insurance cover it? From what I am reading here, it appears the information is stored over a 24 hour period on a hard drive and if more room is needed for more data, an SD card can be inserted. BD
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."