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News & Press Releases

NorthEast Monitoring obtains FDA approval for LX Sleep® home sleep test for assessing OSA

Maynard, MA (OPENPRESS) February 6, 2009 - NorthEast Monitoring, Inc. (Maynard , MA) announced that it has obtained FDA approval for LX Sleep®, a software product that diagnoses OSA from data collected during a simple, overnight, unattended, at-home, sleep test.  The equipment consists of NorthEast’s flagship OxyHolter® (oximetry plus Holter) product and the recently approved LX Sleep® software.  NorthEast will sell and market the product worldwide through its extensive line-up of Channel Partners as well as through new OEM relationships with other partners. 

Link to article on OPENPRESS

View press release, February 6, 2009 (pdf file - 353 KB)

 

Portable Sleep Test Deemed "Very Reliable" for Diagnosing OSA

Subtitle: OxyHolter® from NorthEast used in the study performed by Jordan C. Stern, M.D., Conor Heneghan, Ph.D.
Source: The Sleep Review - The Journal for Sleep Specialists

October 8, 2008 - New research has deemed Holter oximeters “very reliable” for the in-home diagnosis of OSA in adults in children. The research was presented at the 2008 American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting in Chicago.

The study was composed of 120 patients over a 4-month period during which the participants used Holter oximeters for home sleep testing. The oximeters registered a 97% data recovery rate and averaged a comfort score of 2 on a scale of 1 to 10 (1 being the most comfortable).

The authors, Jordan C. Stern, M.D., principal investigator,. and Conor Heneghan, Ph.D., determined that the Holter oximeters are a reliable device for the home diagnosis of obstructive sleep apnea, and are useful in measuring outcomes for the treatment of OSA in adults and children.

For more information contact Info@NEMon.com to request a copy of the research paper on which this news article is based. Please provide your complete contact information (mail, email, phone, FAX) when requesting this article.

 

Research shows OxyHolter® and sleep analysis software* represents a new, easy to use, and reliable device for the home diagnosis of obstructive sleep apnea

Chicago, IL (REUTERS) September 23, 2008 – A small, portable device used for the home diagnosis of obstructive sleep apnea has been deemed very reliable, according to new research presented at the 2008 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO, in Chicago, IL.

According to the study, authored by researcher Dr. Jordan Stern, M.D., principal investigator, with support from NorthEast Monitoring, Inc. and BiancaMed, Ltd., 120 patients over a four-month period used Holter oximeters for home sleep testing, registering a 97 percent data recovery rate during that period. Furthermore, patients reported an average comfort score of 2 (on a scale of 1 to 10, where 1 is the most comfortable). As a result, the authors have determined that Holter oximetry represents a new, easy to use, and reliable device for the home diagnosis of obstructive sleep apnea, useful in measuring outcomes for the surgical and non-surgical treatment of obstructive sleep apnea in adults and children.

Sleep apnea, which affects over 10 million Americans, with an estimated additional 10 million undiagnosed, is characterized by loud snoring interrupted by frequent episodes of totally obstructed breathing (obstructive sleep apnea). Serious episodes last more than ten seconds each and occur more than seven times per hour. Apnea patients may experience 30 to 300 such events per night. These episodes can reduce blood oxygen levels, causing the heart to pump harder.

Recently, the Centers for Medicare & Medicaid Services (CMS) changed their national coverage determination to include Type II, III, and IV devices for home sleep testing for sleep disorders including obstructive sleep apnea.

 

NorthEast Monitoring announces the DR200 Series with 14-day Holter and 30-day Event recorder capability all in one unit.

Subtitle: NorthEast Monitoring, Inc. announced that it has released the DR200 Series Holter + Event recorders. The series is comprised of two recorders – the DR200/HE Combination Holter + Event and the DR200/E “Tel-a-heart” event-only recorder.

Maynard, MA. March 11, 2008 - The DR200/HE is the industry’s first combination 14-day Holter plus 30-day Event recorder. It can be deployed to a patient in either Holter or Event mode. In Holter mode with a single, fully charged AA battery and a 1GB data card, the unit can operate as a 14-day Holter. It is available with 3-, 5- or 7-lead patient cables. The DR200/HE is compatible with NorthEast’s flagship software product, Holter LX Analysis. With 14-day Holter capability and the likelihood of reimbursement for multi-day Holter studies, doctors now have a more cost effective way of insuring they’ll capture elusive cardiac events – every beat, all the time. It is the best single, Holter/Event solution for most practices and businesses seeking to minimize their capital expense while maximizing their good medicine.

View press release, March 11, 2008 (pdf file - 336 KB)

 

OXYHOLTER® FROM NORTHEAST MONITORING, INC.

Subtitle: Currently used for Long Term Oxygen Therapy (LTOT) and Obstructive Sleep Apnea Syndrome (OSAS), Addition of LX Sleep Software Will Add Apnea Hypopnea Index (AHI)

View article that appeared in "Medco Forum", November, 2007 (pdf file - 1.25 MB)

Spanish translation of article that appeared in "Medco Forum", November, 2007 (pdf file - 447 KB)

View article that appeared in "Family Practice Medicine", October, 2007 (pdf file - 509 KB)

 

NorthEast Monitoring obtains 510(k) for Atrial Fibrillation detection in DR200 Series

Maynard, MA. (OPENPRESS) June 3, 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.

View press release, June 3, 2007 (pdf file - 314 KB)

 

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.

View press release, December 18, 2006 (pdf file - 308 KB)

 

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

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