Propeller Health has received 510(k) approval from the US Food and Drug Administration for its Propeller platform.
The approval allows to market the platform in association with medications using GlaxoSmithKline’s (GSK) Diskus dry powder inhaler (DPI) device for asthma and chronic obstructive pulmonary disease (COPD).
In March this year, the 510(k) approval also granted to use the platform in association with medications using Boehringer Ingelheim’s Respimat inhaler for COPD.
Under the approval, the Propeller system currently can be used with DPI medications using GSK’s Diskus device such as Advair Diskus, Flovent Diskus and Serevent Diskus, as well as Boehringer’s Respimat device such as Spiriva Respimat, Combivent Respimat, Striverdi Respimat and Stiolto Respimat.
Propeller Health CEO and co-founder David Van Sickle said: "Today we’re excited to announce back-to-back FDA clearances that demonstrate our leadership and commitment to a singular goal: moving the field of respiratory health forward."
Propeller platform has been designed to help patients and their physicians better understand asthma and COPD, in addition to improving symptoms and outcomes of these chronic respiratory diseases.
Through using sensor technology, software, and services, the platform is said to remotely monitor use of inhaled rescue and controller medications in asthma and COPD. It also analyzes patient trends, and provides regular feedback.
Image: Propeller Health has obtained FDA approval for its Propeller platform to use with GSK’s Diskus inhaler and Boehringer’s Respimat inhaler. Photo: courtesy of PRNewswire/ Propeller Health.