NorthEast Press

Maynard, MA. (OPENPRESS) June 3rd, 2007 – NorthEast Monitoring has obtained approval from the FDA to sell its DR200 Series devices with automatic atrial fibrillation (AFIB) detection. Until now, the stand-alone DR200 series “Tel-a-heart” Event Recorders and the DR200/HE Combination Holter and Event recorders were sold only in the user activated (DR200/E) configuration for the Event Recorder. Now, 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 record Events that the patient self-identifies by pressing the Event button. This auto-plus-manual mode gives 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 helps medical staff quickly review Holter ECG data. It automatically identifies and categorizes 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. The algorithm was extensively tested against the standard ECG database known as the MIT-BIH Arrhythmia Database, in which there are known examples of cardiac anomalies,
among them atrial fibrillation, that must be accurately detected without showing a propensity for indicating false positives – both important criteria in qualifying AFIB software. In the 510(k) submission, the DR200 automatic AFIB detection system accurately detected and confirmed the incidences of atrial fibrillation, with a low incidence of false positives, in the MIT-BIH Arrhythmia Database. In preliminary in-house testing, the DR200 series was shown to have a much lower false positive rate than competitive units already in the US market and approved for such use.

Keywords: Holter, Event Recorder, AFIB detection, DR200, ECG, Arrhythmia, Atrial fibrillation, Cardiology

NorthEast Monitoring Creates OxyHolter – Holter and Pulse Oximetry in a Single, Ambulatory Unit

Maynard, MA. (OPENPRESS) December 18th, 2006 – NorthEast Monitoring has produced the OxyHolter, a combination recorder for Holter and pulse oximetry. The resultant synchronized data set helps identify the correct causal relationship and sequence of events for inter-related episodes of stress in either cardiac or pulmonary patients. Until now, measurements had to be made with two separate units and the time correlation between the units was susceptible to all kinds of errors. Now, with the OxyHolter, those measurements are made on the same time scale, by one ambulatory (Holter) unit, and analyzed by the same LX Analysis software. The analysis software is also available from NorthEast Monitoring.

The OxyHolter is based on existing DR180+ Holter technology and uses one of the three standard Holter channels to receive input from the specially-designed oximetry cable. Oximetry data is obtained from a Nonin finger probe. Active amplifiers in the cable have been separated from the more often-replaced patient elements of the cable to lower the cost of the consumables.

Applications for the OxyHolter include standard 24+ hour studies in the following areas: cardiology, sleep apnea, first pass diagnostic separation of pulmonary versus cardiac issues, DME (oxygen) providers. “Recently the CMS has given very helpful guidance on the ordering, handling and analysis of overnight oximetry studies and we think that should open the way for the DME’s and others to make OxyHolter the first choice for collecting synchronized cardiac and SPO2 data,” says Scott Winick, Director of Sales and Marketing at NorthEast. “The OxyHolter meets all the criteria to prevent data tampering and minimize any potential conflicts of interest in the chain of events from delivery, hook-up, data transmission, analysis and report generation.”

The purely cardiologic uses of the OxyHolter are reimbursed under Medicare CPT codes 93231, 93232, 93233. The Oximetry portion is reimbursed under CPT code 94762.

Keywords: Holter oximetry SpO2 OxyHolter

For more information, contact Scott R. Winick at SWinick@NEMon.com, NorthEast Monitoring,
2 Clock Tower Place, Suite #555, Maynard, MA 01754, or Info@NEMon.com