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Vasomedical-BIOX 2301 for Monitoring of ECG and Blood Pressure Gets 510(k) Clearance

April 12th, 2010 Smit Shah Cardiology, Medicine

1222211ddd.jpgThe FDA has given regulatory clearance to Vasomedical‘s BIOX 2301 Combined ECG Holter and Ambulatory Blood Pressure Monitoring Recorder and Software Analysis System. The 2301 is currently approved for sale in Europe, and is the only FDA cleared device which combines holter-type ECG recording and blood pressure monitoring.
Some stats from the product page:

  • Modes Of Operation: ECG, ABPM & Combined ECG & ABPM
  • Interactive 3-Channel ECG & ABPM recording & storage for 24 Hours
  • Wireless infrared port for real-time ECG & ABPM verification
  • Pacemaker detection
  • Press release: Vasomedical Announces FDA 510(k) Clearance on the First Combined ECG Holter and Ambulatory Blood Pressure Monitoring System…
    Product Page: Vasomedical-BIOX 2301…

    Smit Shah

    Smit Shah is a biomedical engineer currently working as a consulting analyst at Accenture. He has a Masters in Engineering Management from Duke University. When not working, he enjoys cooking, concerts, and exploring New York City.

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