U.S. 510(K) Clearance for Adherium’s Smartinhaler for AstraZeneca’s Symbicort Aerosol

The U.S. FDA has cleared Adherium’s new SmartTouch for Symbicort® inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.


Adherium’s innovative Smartinhaler™ platform integrates a Bluetooth-enabled sensor and smartphone application to detect and record actual usage of inhaled medications. The goal is to provide patients and physicians with critical data that can increase adherence to inhaled medication regimens, resulting in improved management of chronic respiratory conditions.

The SmartTouch for Symbicort® is a device installed onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is the latest product to be added to Adherium’s product portfolio to assist patients, who suffer from respiratory conditions such as asthma and COPD, with adherence.

Adherence to medication is crucial for the successful management of many chronic diseases, but it is common for patients with respiratory conditions to only take between one third and one half of their prescribed medications.

Company comments

Arik Anderson, CEO of Adherium, said: “The SmartTouch for Symbicort is the most advanced Smartinhaler product to date for Adherium and a key product in our strategic collaboration with AstraZeneca by bringing the benefits of digital monitoring to patients and their physicians. 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. This is Adherium’s third U.S. 510(k) clearance to market. In addition, the company has secured clearances in Europe, Canada, Australia, China, Singapore and New Zealand.”


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