FDA Clears Selling Automatic Afib Detection with DR200


May 13, 2008

Northeast Monitoring received clearance from the FDA to sell its DR200 Series devices with its automatic atrial fibrillation (Afib) detection solution, enabling the company to link the stand-alone DR200 series, “Tel-a-heart” Event Recorders and the DR200/HE Combination Holter and Event recorders.

With automatic AFib detection, the unit continuously “watches” the patient’s ECG data and automatically identifies and records events the patient might have missed. In addition, the DR200 units will reportedly record events that the patient self-identifies by pressing the 'Event' button. This auto-plus-manual mode is designed to give an enhanced picture of the patient’s cardiac situation.

Although the 510(k) approval for the use of the algorithm in the DR200 Series is new, the proprietary NorthEast algorithm itself has been in use for years inside NorthEast’s Holter LX Analysis software. LX Analysis software aims to help medical staff review Holter ECG data. It is said to automatically identify and categorize many cardiac issues from the ECG data, among them atrial fibrillation. The algorithm was ported forward to the DR200 Series Event Recorder and verified to be effective as part of the recent submission to the FDA.