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FDA grants 501(k) clearance for platform used in association to treat asthma, COPD
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The FDA has granted Propeller Health 501(k) clearance to market its Propeller platform in association with GlaxoSmithKline’s Diskus dry powder inhaler device for asthma and COPD, according to a company press release.
“501(k) clearance of our platform with inhaler devices from leading global respiratory companies GlaxoSmithKline and Boehringer Ingelheim opens the doors for millions of patients to expect and achieve something better in asthma and COPD,” David Van Sickle, PhD, CEO of Propeller Health said in the release.
An FDA-cleared digital health platform, Propeller’s platform remotely monitors use of inhaled rescue and controller medications in asthma and COPD, analyzes patient trends and provides regular feedback.
Under the clearance, the system can now be used in association with medications delivered by Boehringer Ingelheim’s Respimat device and medications using GlaxoSmithKline’s Diskus.
“I’m encouraged by the potential of combining digital services with existing therapies to improve outcomes,” David Mannino, MD, professor of medicine in the division of pulmonary, critical care, and sleep medicine at University of Kentucky, said in the release. “Adding these important medications to propeller’s system will help improve care for many patients with COPD and asthma across the U.S.”