Teva’s Digital Inhaler Now FDA Cleared
Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020.
Teva’s ProAir Digihaler is indicated for the prevention and treatment of bronchospasm among patients aged four years or older with reversible obstructive airway diseases such as asthma or COPD, as well as for the prevention of exercise-induced bronchospasm (EIB) among this same group.
The prescription digital albuterol dispenser houses a built-in module that detects and measures each use, and sends the recorded information to a Bluetooth-connected mobile app. With this, patients can review their inhaler usage and share the data with their doctor.
Why it matters
According to 2016 data from the CDC, roughly 26.5 million adults and children living in the US have asthma, and approximately 1.7 million emergency department visits with asthma as the primary diagnosis occurred in 2015. Easily recording inhaler use with the device not only helps patients and providers monitor adherence, but correct any errors when dispensing treatment.
“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. That’s what makes a product like this so important to doctor-patient discussions,” Dr. Tushar Shah, SVP of global specialty clinical development at Teva Pharmaceuticals, said in a statement. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.”
What’s the trend
This month’s approval comes a bit over three years after Teva announced its purchase of Gecko Health Innovations, a Cambridge, Massachusetts-based maker of smart inhalers. At the time, Gecko’s leading product was CareTRx, a platform for chronic respiratory disease management that combined a connected sensor device, a data analytics platform, an accessible user interface and behavioral triggers to help asthma and COPD patients manage their condition.
Read More at the Source: Teva’s digital inhaler cleared by FDA | MobiHealthNews
Written by: Dave Muoio
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