According to Adherium, the company has received 510(k) clearance from the FDA for its next generation Hailie inhaler sensor. The new version of the Hailie sensor, which is meant to be used with the Symbicort MDI, includes the ability to capture clinical data in addition to inhaler usage data. Adherium says that the additional capability for monitoring asthma and COPD included in the new sensor will facilitate reimbursement of providers for remote monitoring. The company had announced submission of the 510(k) application in June 2021, at the same time that it announced the appointment of Rick Legleiter as its new CEO.
Adherium Chief Technology Officer Geoff Feakes said, “Today marks an important milestone in Adherium’s commitment to the expansion of our digital respiratory ecosystem, with the 510(k) clearance of our new sensor for AstraZeneca’s Symbicort. The new Symbicort sensor is the first in our new range of digital smart inhalers that will be delivered over the next 12 months providing physiological measures including, inhalation duration, volume, and peak inhalation flow. Our commitment is expanding Adherium’s asthma and COPD medication coverage in the US from 50% to over 80% by volume supporting 18 medications. An important step in enabling asthma and COPD sufferers in receiving increased support assisting with their medication usage and disease treatment. Physiological measures were consistently identified as a key data set to improve patient management and, importantly, access reimbursement in the US to enable the patient population to benefit from this state-of-the-art technology.”
Legleiter commented, “The FDA’s first clearance of our next generation Hailie sensors with physiological measures is a significant regulatory step for the business. The stage is now set for physiological measures to be coupled with our existing adherence sensor capability giving us the total ‘one-two punch’ to deliver the best value proposition of any smart inhaler digital solution in the world. As we deliver our clearly defined development roadmap including new additional physiological enabled sensors and alongside digitally enabled peak flow and spirometers, Adherium will expand its addressable respiratory medication market coverage and establish a preeminent business partnering position for providers, payers and digital health affiliates.”
Legleiter added, “This FDA decision increases the number of 510(k) cleared Adherium devices to ten in the US and represents an unequalled and formidable track record of development and experience by the market leader in respiratory digital health.”
In 2018, Adherium got OTC clearance for the Hailie platform in the US, and the company subsequently launched direct-to-consumer sales.
Read the Adherium press release.
