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.