According to SmartInhaler maker Adherium, the FDA has granted 510(K) clearance for the company’s SmartTouch sensor for use with AstraZeneca’s Symbicort MDI. The SmartTouch device, which fits over the inhaler, records and transmits inhaler usage data via Bluetooth.
Adherium CEO Arik Anderson commented, “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.”
Read the Adherium press release.