Adherium gets US FDA 510(k) to connect remote monitoring sensor for Ellipta inhaler users
Adherium, a New Zealand-based maker of connected respiratory medical devices, has received the US Food and Drug Administration’s 510(k) clearance for connecting its digital monitoring platform with GlaxoSmithKline’s range of Ellipta dry powder inhalers.
The ASX-listed firm offers the Hailie sensor which attaches to an inhaler to remotely monitor and capture medication usage parameters and adherence of patients with asthma and chronic obstructive pulmonary disease. It is part of a remote patient monitoring system which includes a software development kit and API integration tools to enable the capture and real-time sharing of health data through mobile and desktop apps.
Based on a corporate disclosure, the Hailie sensor has been approved to connect with the following Ellipta inhalers: Breo, Anoro, Incruse, Trelegy and Arnuity.
This latest approval follows the clearance Adherium received for connecting Hailie with AstraZeneca’s Symbicort aerosolised inhaler in September last year
WHY IT MATTERS
According to Adherium, the addition of GSK’s Ellipta inhalers to the range of products that connect with Hailie broadens health providers’ access to reimbursement for remote monitoring of prescribed medications for asthma and COPD patients. The company aims to enable reimbursement on 18 branded inhalers in the US by next year.
“With another FDA clearance, we continue to demonstrate our leadership position providing digital solutions for the management of the 8.5 million severe and difficult-to-treat asthma and COPD patients in the US,” said Tara Creaven-Capasso, Adherium’s VP for Quality, Regulatory and Clinical Affairs.
THE LARGER TREND
In June, Adherium signed its first distribution deal in the United Kingdom with Helicon Health to market its Hailie range of sensors and cloud data services.
The company also recently released an updated SDK and a new API to improve Hailie’s connection with customer patient management systems, as well as enable its direct integration with third-party clinical apps.
According to Research and Markets, the global digital respiratory devices market may hit $405.1 million in value by 2030, growing at a 27.31% CAGR from 2021.