Smart inhaler company Adherium announced last week that it has received 510(k) clearance for over-the-counter sales of its inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, called the SmartTouch for Symbicort.

Adherium — which is headquartered in San Mateo, California, but holds currently offices in Melbourne, Australia; Auckland, New Zealand; and Amstelveen, The Netherlands — makes a device that grafts onto a patient’s inhaler to monitor and encourage medication adherence as part of a self-management plan. It is designed to be easy to install and remove and includes three buttons that help patients access the audio visual-reminders, battery monitoring, and Bluetooth low-energy pairing features. The inhaler can also help clinicians pinpoint when and how someone is misusing an inhaler, for instance holding it upside down or inhaling at the wrong time.

The sensor was first cleared by the FDA in September and is intended for use by patients with respiratory conditions such as asthma and COPD.

“Over-the-counter sales of our Smartinhaler sensor for the Symbicort aerosol inhaler continues the advance of our vision for stronger partnerships between patients and physicians by making adherence to personal management plans easier,” Arik Anderson, CEO of Adherium, said in a statement. “We are now well positioned to launch in the US, following successes in Europe and Australia. We are providing clinically-proven monitoring to support patients in adopting their physicians’ guidance into their daily lives, and so close the gap between science and real-world care.”

Anderson spoke about its direct-to-consumer plans earlier this year when he mentioned that Adherium took inspiration from other successful direct-to-consumer health products, such as AliveCor’s smartphone-connected ECG Kardia or Mylan’s EPI-pen. At the time, he said that the company was looking at a subscription pricing model in the area of $10 monthly, and taking steps to establish a complementary direct-to-payer channel for the device as well.

Although entry into the US market would potentially place Adherium in direct competition with other digital respiratory health companies such as Propeller Health and Cohero Health, Anderson said that the size of the country’s asthma and COPD market should leave enough space for everyone.

“There are about 25 million asthmatics in the US, another 15 million with severe to moderate COPD that would dramatically benefit from adherence technology,” he said at the time. “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.”