North America

Teva Pharmaceutical's AirDuo Digihaler gets FDA green light

The technology has a built-in sensor that can send usage data to a corresponding smartphone app.
By Laura Lovett
03:14 pm

This morning Teva Pharmaceutical Industries announced that the FDA greenlighted its AirDuo Digihaler, a sensor-enabled inhaler. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user's smartphone. This information can also be sent to the user’s provider. 

The sensor technology is also able to monitor inspiratory flow rates, according to a statement. 

The AirDuo Digihaler is aimed at helping to prevent bronchospasms, and is not meant to be used as a rescue inhaler, according to the company. This latest FDA classification clears the technology for individuals over the age of 12 years. 


Asthma is a common condition impacting about one in 12 people, or 25 million in the US, according to the CDCThat number has been growing since 2001, according to the organization. 

While there is no cure for asthma, it is often treated with inhalers and medications. The company is pitching this technology as a way for patients and providers to keep better track of the condition and inhaler usage. 

“With this approval, patients can now track how frequently they are using their inhalers. Granting patients, the ability to track their maintenance inhaler use may help inform conversations with their doctors about treatment adherence and proper technique,” Dr. Tushar Shah, global head of specialty clinical development at Teva Pharmaceuticals, said in a statement. 


Connected inhalers have been in the digital health world for some time now. In fact, this isn’t Teva’s first FDA nod for a connected inhaler. In December the Israel company got FDA marketing approval for its ProAir Digihaler. At the time the company revealed that the device will first become available this year through a “small number” of healthcare system pilot partnerships, with a full national launch planned for 2020.

Propeller Health and Adherium are some of the biggest names in the smart inhaler world. In 2018 Adherium landed a 510(k) clearance for over-the-counter sales of its Hailie sensor. 


“The approval of AirDuo Digihaler is an important step for Teva and the respiratory community to create a technology platform for use in asthma management along with the previously-approved ProAirDigihaler,” Sven Dethlefs, EVP of global marketing and portfolio, said in a statement. “This technology aims at delivering innovations through cloud-based services with the target to provide new insights to guide treatment choices for caregivers to help them improve outcomes for asthma patients.”


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