Digital health business Adherium has received clearance from the U.S. Food and Drug Administration for an inhaler sensor called SmartTouch to be used with AstraZeneca’s Symbicort aerosol inhaler for patients with COPD and asthma. Although Adherium has received approval for previous iterations of its tracking device, CEO Arik Anderson explained the significance of the 510(k) clearance in a phone interview.
Asked how its approach contrasts with that of similar companies such as Propeller Health and Cohero Health, Anderson said Adherium has been around for a longer period of time and methodically validating its technology. The company, which is based in Melbourne, Australia, got its start in 2001. Its initial focus was developing technology for respiratory patients and validating it. Previous regulatory approvals have been for devices geared for patients and physicians. The latest approval is the culmination of a partnership with AstraZeneca begun two years ago.
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“Initially we were looking at stand alone inhaler devices with sensors able to detect when the device was activated,” Anderson said. “We have evolved beyond whether the patient is using the device to whether the patient is using the device effectively…It helps doctors understand what is going on in their patients’ lives.”
The company claims clinical outcomes data have shown proven that it can significantly improve adherence in adults and children. To date, Adherium has sold 100,000 of its Smartinhaler devices.
SmartTouch for AstraZeneca’s Symbicort inhaler
The latest version of SmartTouch is designed to ensure that the physician has feedback on how the patient is interacting with the inhaler so interactions with patients are more meaningful.
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It records the date and time the inhaler is used and automatically transmits this information to an app on the patient’s phone or tablet, according to a news release. The SmartTouch also archives patient medication usage patterns, so doctors can review the information and make more informed decisions. The device is designed to be used for home monitoring programs, such as hospital re-admission prevention programs.
Although he could not confirm when AstraZeneca planned to roll out its device using SmartTouch in the U.S., Anderson said he expected a U.S. pilot for direct to consumer use to happen sometime in the first half of 2018.
Adherium is currently in non-U.S. markets such as Europe, Canada, Australia, China, Singapore and New Zealand.
Anderson said he sees potential to expand the company’s technology further into smart injectibles and other applications for chronic conditions.
Photo: Getty Images
