SAN MATEO, Calif. – The U.S. Food and Drug Administration has cleared Adherium’s Smartinhale sensor for over-the-counter sales. The sensor was cleared for use in AstraZeneca’s Symbicort aerosol inhaler to monitor and promote asthma and COPD medication adherence as part of a self-management plan. It automatically records the date and time the inhaler is used and sends the information to an app on the user’s smartphone or tablet. “Over-the-counter sales of our Smartinhaler sensor for the Symbicort aerosol inhaler continues the advancement of our vision for stronger partnerships between patients and physicians by making adherence to personal management plans easier,” said Arik Anderson, CEO of Adherium, in a statement. “We are now well positioned to launch in the U.S., following successes in Europe and Australia.” OTC clearance means that Adherium’s Smartinhaler can now be sold directly to consumers, including through pharmacies and online, without the need for the patient to first obtain a prescription.
