Propeller Health on Wednesday said the FDA granted 510(k) clearance for its Propeller digital health platform in association with drugs using GlaxoSmithKline's Diskus dry powder inhaler for asthma and chronic obstructive pulmonary disease (COPD), after having gained similar clearance of the platform in March for medications using Boehringer Ingelheim's Respimat inhaler for COPD. The platform allows patients with chronic respiratory disease to track their medication usage and better follow their treatment regimens, with CEO David Van Sickle saying the back-to-back regulatory decisions represent "a big expansion of the potential market" for Propeller's products.
Propeller Health specified that the system can now be used with Advair (salmeterol/fluticasone), Flovent (fluticasone) and Serevent (salmeterol), which are delivered via the Diskus device, as well as Spiriva (tiotropium), Combivent(ipratropium/albuterol), Striverdi (olodaterol) and Stiolto (tiotropium/olodaterol), which make use of the Respimat inhaler.The platform, which features sensor technology, software and services, remotely monitors use of inhaled asthma and COPD drugs, analyses patient trends and provides regular feedback, the company said. Propeller Health added that the system also aims to increase therapy adherence, predict oncoming asthma and COPD symptom exacerbations, and help reduce the frequency of symptoms and exacerbations.
The company noted that the platform gained FDA 510(k) clearance in 2012 for patients with chronic respiratory disease for use with medications delivered by pressurised metered-dose inhalers, while an updated version of the system was cleared in the US in May 2014.
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