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Adherium Gains Clearance for OTC Sales of Hailie Sensor
Devices Submissions and Approvals
The FDA granted additional 510(k) clearance for the Adherium digital health platform, clearing over-the-counter sales of its Hailie sensor, a device designed for use with asthma inhalers.
The sensor, previously known as Smartinhaler, attaches to a patient’s asthma or COPD inhaler to monitor and encourage consistent use, allowing patients to self-manage their asthma treatment.
The clearance expands access to Adherium’s Hailie online system to consumers using Teva’s ProAir HFA and GSK’s Ventolin HFA and Flovent HFA, medications for bronchospasms and asthma.