MADISON, Wis., Nov. 7, 2016 /PRNewswire/ -- Propeller
Health, the leading digital solution for respiratory medicine,
today announced U.S. Food and Drug Administration 510(k) clearance
to market its Propeller platform for use with GSK's Ellipta®
inhaler, the pharmaceutical company's innovative, patented, dry
powder inhaler (DPI). The sensor for the Ellipta inhaler was built
and cleared as part of a development agreement and R&D
collaboration between Propeller and GSK that was announced on
December 1, 2015.
"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."
This FDA clearance follows CE Mark and Health Canada
registration for the device and system earlier this year.
Propeller is FDA-cleared to help patients and their physicians
better understand asthma and COPD, and help to improve the symptoms
and outcomes of these chronic respiratory diseases. With
proprietary sensor technology, software, and services, Propeller's
digitally-guided therapy platform integrates information from
multiple sources, including connected medications, then uses
machine intelligence to help individuals manage their
condition.
Dave Allen, head of respiratory
R&D at GSK, said, "While it is still in the early stages of
development, the emerging field of digital healthcare holds great
promise for respiratory medicine. 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."
The Propeller Health platform has been used by patients with
asthma or COPD in over 45 commercial programs across the US,
including major healthcare systems, payers, employers and other
commercial partners. This clearance marks the eighth FDA clearance,
as well as the eighth international clearance, received by
Propeller to date.
About Propeller
Propeller empowers people with asthma and COPD to live
measurably better lives. In 2010 Propeller set out to modernize
respiratory medicine, empower people to minimize the impact of
asthma and COPD on their daily lives, and connect them to their
physicians, environment and community. Propeller's
information-powered approach to respiratory management guides
physicians and patients to the optimal path of therapy for each
individual. With connected inhalers, digital interfaces, and real
time personalized insights, participants receive personal guidance
and expert direction anytime. Backed by 3M Ventures (NYSE: MMM), SR
One, Hikma Ventures (LON: HIK),, Safeguard Scientifics (NYSE: SFE),
Social Capital and other investors, Propeller has been used by
patients with asthma or COPD in over 45 commercial programs across
the US at major healthcare systems, payers, employers and other
commercial partners. The company has been recognized as the
recipient of the American Telemedicine Association's 2016
President's Award for Innovation in Remote Healthcare and as one of
the top "Fierce 15" medical device companies in 2015 by
FierceMedicalDevices. For more information visit:
www.propellerhealth.com
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SOURCE Propeller Health