Propeller Health said today that it won 510(k) clearance from the FDA to market its Propeller platform with GlaxoSmithKline‘s (NYSE:GSK) Ellipta inhaler. A sensor for the dry powder inhaler was built as a part of a 1 year-long development and R&D collaboration between Propeller and GSK.
This marks the 8th clearance for Propeller’s connected inhaler platform.
The Madison, Wisconsin-based company won CE Mark approval and Health Canada registration for the use of its connected platform with the Ellipta inhaler earlier this year.
Propeller’s sensor technology and software is designed to be used by patients and physicians to keep track of symptoms and outcomes for chronic respiratory diseases such as asthma and COPD. The platform can integrate data from multiple sources, like connected devices, and uses machine learning to help patients manage their condition, according to Propeller.
“Today, we are pleased to announce the FDA clearance of the Propeller platform for use with GSK’s Ellipta inhaler,” co-founder & CEO David Van Sickle said in prepared remarks. “Inclusion of GSK’s Ellipta inhaler in Propeller’s digitally-guided therapy platform is an important step in our goal of modernizing the management of respiratory disease. We look forward to working closely with GSK to deploy sensors for the Ellipta inhaler in the U.S. and abroad, in the near term.”
“While it is still in the early stages of development, the emerging field of digital healthcare holds great promise for respiratory medicine,” GSK respiratory R&D head Dave Allen added. “The approval of the Propeller platform for use with the Ellipta inhaler will help us understand how patients interact with the Ellipta inhaler accurately and in real-time. By exploring the benefits of sensor technology in this way, we hope to gain valuable insights into usage patterns with the ultimate goal of driving improvements in patient care while reducing the complexity and cost of clinical trials.”