Asthmapolis announced today that the US Food and Drug Administration (FDA) has granted its asthma sensor and companion software 510(k) clearance. The company's device is a sensor that sits atop (most) inhalers used by patients who have asthma or COPD. The sensor transmits data to a companion app on the user's mobile phone every time the inhaler is used. The app can then track the time and location of each medication discharge, which can then be used to help patients and their care givers better understand their asthma triggers. The company submitted its asthma system to the FDA on June 1, 2012 and received clearance on July 2, 2012, according to regulatory filings.
The company has described its device as ”small and lightweight” and “easy to mount securely on the end of most inhalers, and simple to transfer to a new canister,” according to the company's website. “Lights on the device let you know when it has detected use, and also show remaining battery level.”
“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,” Inger Couture, Chief Regulatory Officer of Asthmapolis, said in a written statement. “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.”
Earlier this year Asthmapolis announced that it was partnering with Dignity Health, formerly known as Catholic Healthcare West, to equip its Sacramento-based asthma patients with its inhalers sensors to send real-time breathing data to physicians’ smartphones. The company is currently conducting similar studies with the City of Louisville and Norton Healthcare in Kentucky.
Asthmapolis has also previously announced partnerships with organizations that include the Air Pollution and Respiratory Health Branch at the CDC as well as the California HealthCare Foundation. At the end of 2011, the company announced plans to add connectivity to its device through the Qualcomm 2net platform, too.
Back in April 2009 MobiHealthNews reported that Asthmapolis co-founder and CEO David Van Sickle, then a recent Robert Wood Johnson Foundation Health and Society Scholar in the Department of Population Health Sciences at the University of Wisconsin-Madison, was developing a GPS add-on for asthmatics’ inhalers to map where and when environmental exposures cause asthma symptoms–as well as alert users and encourage them to puff on the “rescue inhaler.” The project was also aimed at mapping the unknown causes of asthma in the environment.
“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,” Van Sickle stated in the recent FDA announcement. “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.”