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Adherium bags US FDA approval to sell inhaler sensor directly to consumers

Adherium Ltd. said the U.S. Food and Drug Administration granted the company 510(k) clearance to sell its inhaler sensor directly to consumers without a prescription.

The regulator granted over-the-counter clearance for Adherium's Smartinhaler sensor, a device intended to be installed onto AstraZeneca PLC's asthma inhaler Symbicort. The device monitors a patient's usage of the inhaler and sends that data to an app on the user's phone or tablet as part of a self-management plan.

The San Mateo, Calif.-based company develops digital health technology for chronic diseases, such as asthma and chronic obstructive pulmonary disease.