New dry-powder asthma inhaler receives FDA clearance
Propeller Health, a producer of digital products for respiratory medication, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the GSK's Ellipta inhaler and platform, a treatment for asthma featuring a patented dry-powder inhaler.
"Today, we are pleased to announce the FDA clearance of the Propeller platform for use with GSK's Ellipta inhaler," said David Van Sickle, CEO and co-founder of Propeller. "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."
The platform uses a trio of sensors, software and services to gain a better insight into individuals' asthma and COPD. Using the digital therapy allows for an integration of information across different sources with machine learning to specialize care on a patient’s level, further easing the way toward patient managed care. Propeller hopes to further develop their respiratory disease management platforms, currently used in more than 45 hospital systems and partners across the U.S., to be included in asthma and COPD related care.
"While it is still in the early stages of development, the emerging field of digital healthcare holds great promise for respiratory medicine,” said Dave Allen, head of respiratory R&D at GSK. “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."