Adherium, the makers of inhaler sensors, has received 510(k) US-FDA clearance for the sales of its Hailie sensor, previously known as Smartinhaler. The individual versions of this device were previously cleared for use with the asthma inhalers like Ventolin HFA, ProAir HFA, and Flovent HFA.

Arik Anderson, the CEO of Adherium, said “This latest clearance kicks off our official entry into the US consumer market, giving the tens of millions of US patients suffering from chronic respiratory conditions their own sidekick for asthma and COPD.”

The Hailie consists of a sensor and an app that creates data from that sensor, which will be made available to patients, caregivers, parents, or clinical team. A reminder is also set in the inhaler to use it by making a sound, lighting up, or vibrating. This inhaler can also help clinicians to pinpoint if anyone is using it wrong.

Anderson said, “There are about 25 million asthmatics in the US, another 15 million with severe to moderate COPD that would dramatically benefit from adherence technology; We’re talking about 40 million patients that are potential targets. The US market is huge. And we’ve got a handful of companies that are looking at going and demonstrating how adherence can change that outcome. Frankly, it’s good for all of us that there are multiple companies involved in that.”