Nexus6 Receives FDA Clearance for Latest Smartinhaler

Nexus6 Ltd, has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for its new SmartTouch inhaler monitoring device.


It is well known that it is difficult for patients to remember to take daily preventative medications over a long term as required for the management of many chronic diseases. For respiratory conditions such as asthma, it is common for patients to take between 30% and 50% of prescribed preventative medications.


Nexus6 Ltd, a global leader in digital health solutions for respiratory medications, has received US FDA clearance-to-market for its latest generation of Smartinhaler called the SmartTouch™.


The SmartTouch installs on to a patient’s inhaler and records the date and time the inhaler is used. This information is stored in the SmartTouch memory, and is automatically transmitted wirelessly to the patient’s phone, tablet, and/or personal computer. The SmartTouch builds up a history of patient medication usage patterns and encourages medication adherence.


This is highly effective in helping a patient to remember to take their daily preventative medications as part of an ongoing self-management plan.


It is also of significant value to the patient’s physician. With the patient’s permission, the physician can review this information to help make evidence based decisions on how best to meet their patient’s needs. In the absence of such information, accurately assessing individual patient medication requirements is challenging.


The SmartTouch is also of value in home monitoring programs, such as hospital re-admission prevention programs, where maintaining medication adherence after hospital discharge is a key objective.


COPD and asthma are major chronic conditions that impact tens of millions of people in the United States, and hundreds of millions of people globally.  COPD and asthma where suboptimal medication adherence is recognized as a source of morbidity for patients and financial burden to payers.


Garth Sutherland, Chief Executive Officer of Nexus6 said “Nexus6 was established in 2001 and has been dedicated to developing Smartinhaler technology ever since. The SmartTouch is the latest generation in Nexus6’s Smartinhaler range. With each new generation our Smartinhalers get smaller, easier to use, and incorporate more sensors that generate higher quality data, and higher levels of medication adherence. The SmartTouch supersedes our SmartTrack device, which is proven in clinical trials to double preventative medication adherence levels”.