FDA clears Asthmapolis’ sensor system and associated software

Asthmapolis announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its asthma sensor system and associated software to healthcare providers and their patients.

"We are thrilled to have achieved this important milestone to support our mission of providing tools to help patients and their healthcare providers better understand and control their asthma symptoms," noted Inger Couture, Chief Regulatory Officer of Asthmapolis. "Despite all we know about asthma and how to treat it, the majority of patients still do not have the disease under control, and traditional approaches to self-management have been time-consuming and complicated. The Asthmapolis technology makes it much easier to track symptoms and use of metered dose inhalers, allowing patients, their families and their doctors to gain a valuable new perspective on the disease."

The Asthmapolis inhaler sensor sits on top of inhalers that are used by patients with asthma and COPD. When an inhaler is used, the sensor works with an accompanying mobile phone application to capture information about day-to-day burden and management. By automatically tracking the time and location of events, the tools – which include web and mobile phone applications – improve awareness of level of disease control and provide a greater understanding of triggers and patterns in symptoms in individuals and communities. The sensor data is also used to provide personalized guidance and targeted education drawn from the National Asthma Education and Prevention program.

"In addition to driving better patient-physician communication about asthma management, the tool also gives physicians the ability to quickly identify how patients in their population are doing and take steps to help patients get their disease under control," said David Van Sickle, co-founder and CEO of Asthmapolis. "Our mission is to make it easier for patients and their physicians to do a better job of managing asthma with less effort than traditionally required."

"Asthmapolis is a novel system devised to facilitate what could be termed 'health networking' between the patient and the healthcare system," noted Robert F. Lemanske, Jr., M.D., who heads the Division of Pediatric Allergy, Immunology and Rheumatology at the University of Wisconsin School of Medicine and Public Health. "The geographic tracking of inhaler use can provide novel information regarding environmental factors that trigger acute events in individual patients. Avoidance of such environments would further improve overall asthma control and reduce healthcare costs."