Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler.
The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence.
The device records the time and date that a patient uses their inhaler and transmits the data to an app on the user’s phone or tablet. This feature allows users and physicians to track a patient’s medication usage patterns, Adherium reported.
“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,” Adherium CEO Arik Anderson said in prepared remarks. “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.”
The SmartTouch for Symbicort product is designed to make inhaler installation and removal simple, particularly for older patients with chronic obstructive pulmonary disease, according to Adherium. The device has three buttons with audio and visual reminders.