Adherium Ltd. said the U.S. Food and Drug Administration granted 510(k) clearance for over-the-counter sales of its Hailie sensor for asthma inhalers.
The approval expands the usage of the Hailie online platform to include the ProAir inhaler manufactured by Teva Pharmaceutical Industries Ltd. and the Ventolin and Flovent inhalers marketed by GlaxoSmithKline PLC.
The prior approval limited Hailie's use to only AstraZeneca PLC's Symbicort inhaler.
The New Zealand-based healthcare technology company's sensor device attaches to the inhalers to monitor and promote adherence as part of a self-management plan. It does this by tracking medication use and reminding the user when it is time to take doses and by providing access to usage history to better understand patterns in their asthma and chronic respiratory conditions.
Adherium said it is also launching an online portal for healthcare professionals that will provide patient-group data collection and reporting from Hailie sensors.
"This latest clearance kicks off our official entry into the U.S. consumer market," Adherium CEO Arik Anderson said in a statement.