Nexus6 Receives 510(k) Clearance for SmartTrack Electronic Respiratory Medication Adherence Monitoring Solution

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Nexus6 Ltd, a global leader in medication adherence monitoring solutions for inhalation therapies, announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for its new SmartTrack® electronic medication monitor and Respiratory Analyzer software.

Based upon proprietary Nexus6 technology and designed with feedback from clinicians and respiratory researchers, SmartTrack® records and reports patient medication adherence to prescribed inhaled corticosteroid and combination therapies.

SmartTrack® is intended for single-patient use as an electronic data capture system

  • In clinical practice, where health care professionals need to be able to confirm poor patient medication adherence as a cause of suboptimal respiratory disease control
  • In clinical trials, where researchers require accurate medication compliance information to determine the effectiveness of a drug or other intervention under investigation.

Current applications for the SmartTrack® system include the management of Asthma and Chronic Obstructive Pulmonary Disease (COPD). It is estimated that up to 34 million Americans have been diagnosed with asthma during their lifetime, and more than 10 million US adults suffer from COPD. Nexus6 Limited can supply adherence monitors for all major existing inhalation drug delivery devices marketed by global pharmaceutical companies.

Asthma and COPD are only two diseases where poor medication adherence is recognized as a cause of significant waste in worldwide healthcare systems. The New England Healthcare Institute (NEHI) estimates that in the United States alone nonadherence, along with suboptimal prescribing, drug administration, and diagnosis results in as much as US$290 billion per year in avoidable medical spending, and up to US$100 billion each year in excess hospitalization costs.

David Evans, Chief Executive Officer of Nexus6 said “The FDA approval is a very important company milestone, but it is only a starting point for Nexus6, since the SmartTrack® knowledge platform system has broad application in intelligent systems to improve the management of other diseases. We already have commercial contracts in place with global manufacturers of medical devices for treatment of disease states other than asthma and COPD to incorporate our technology into their next generation products”.

About Nexus6
Nexus6 Limited is a privately held developer and manufacturer of solutions to increase patient adherence to therapies, leading to improved disease management and reduced healthcare costs.

Nexus6 Limited
Garth Sutherland, COO
(937) 274 2111 ext 104


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Garth Sutherland
Nexus6 Limited
(937) 274 2111 ext. 104
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