Inhaler monitoring company Adherium has announced the submission of a 510(k) for a new Hailie sensor designed specifically for use with Ellipta DPIs. In September 2021, the FDA cleared another version of the next generation Hailie sensor for use with Symbicort MDIs. The sensors, which snap on to the outside of the device, connect to a cloud-based monitoring platform via Bluetooth.
The earlier generation Hailie platform was cleared by the FDA for over-the-counter sales for use with with ProAir HFA, Ventolin HFA, and Flovent HFA MDIs in 2018, and the company launched sales of Hailie sensors for those inhalers in August of that year. The Hailie web site currently lists sensors for use with a dozen different inhalers, including Turbuhaler, Handihaler, and Diskus products.
Adherium Chief Technology Officer Geoff Feakes commented, “Submitting the market application with the FDA is another key step in the extension of our digital respiratory management ecosystem. Adherium is focused on delivering technology leading respiratory solutions including our next generation of sensors that capture physiological parameters. Physiological parameters were consistently identified as a valuable data set to improve patient management. Clinicians globally have told us of the importance to build on our core adherence capability, extend the range of the clinical respiratory data we capture, and expand our market coverage of inhaled medications. As part of Adherium’s market expansion we intend to roll out additional new sensors with physiological parameters taking our asthma and COPD medication coverage in the US to over 80% of the addressable market volume supporting 18 medications.”
Read the Adherium press release.
