Propeller Health announced Monday the FDA 510(k) clearance to market its Propeller digital health platform for use with GlaxoSmithKline's Ellipta dry powder inhaler. David Van Sickle, CEO of Propeller Health, said that "inclusion of GlaxoSmithKline's Ellipta inhaler in Propeller's digitally-guided therapy platform is an important step in our goal of modernising the management of respiratory disease," adding "we look forward to working closely with GlaxoSmithKline to deploy sensors for the Ellipta inhaler in the US and abroad, in the near term."
Dave Allen, GlaxoSmithKline's head of respiratory R&D, remarked that "while it is still in the early stages of development, the emerging field of digital healthcare holds great promise for respiratory medicine." Allen noted that the approval "will help us understand how patients interact with the Ellipta inhaler accurately and in real-time…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."
The approval follows an R&D collaboration between the companies that was announced in December last year, under which Propeller Health agreed to develop a custom sensor for GlaxoSmithKline's Ellipta inhaler for use in certain clinical trials in asthma and chronic obstructive pulmonary disease.
Propeller Health explained that its platform features proprietary sensor technology, software and services, and integrates information from multiple sources, such as connected medications, "then uses machine intelligence to help individuals manage their condition."
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