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FDA Clears Asthma/COPD Mobile Reporting, Analytic System

Patient feedback screen

Apple/iOS patient feedback screen (Propeller Health)

6 May 2014. Propeller Health in Madison, Wisconsin says the U.S. Food and Drug Administration cleared the latest version of its mobile-device system to record and track maintenance therapy for patients with respiratory diseases, such as asthma and chronic obstructive pulmonary disease or COPD. The new version of the system cleared by the FDA, says the company, can be used to predict flareups, known as exacerbations, among patients with asthma or COPD.

Asthma is a chronic condition where the airways become inflamed and narrow, causing difficulties in breathing, wheezing, tightening in the chest, and shortness of breath. COPD is class of disorders, often caused by smoking, that produces large amounts of mucus and damages the air sacs in the lungs, causing difficulty in breathing. The two main types of COPD are emphysema and chronic bronchitis.

To relieve short-term breathing difficulties, people with asthma and COPD use hand-held rescue inhalers with medication to relieve symptoms such as shortness of breath. Asthma and COPD patients are asked to record their use of rescue inhalers, since the timing, frequency, and events that trigger flare-ups are indicators of disease progression, and can alert physicians if patients’ conditions are getting worse.

The Propeller system, says the company, makes it possible for patients to keep track of their use of inhalers without keeping burdensome diaries. The system has a sensor that fits on the inhaler and measures the amount of medication inhaled by the patient. Data from the sensor are then transmitted via a Bluetooth connection to a mobile app on an Apple-iOS or Android device. The app displays the data to provide feedback for the patient, or can transmit data to a physician.

The new version of the system cleared by FDA has a smaller sensor that uses less energy, thus extending the battery life. The app’s software also has more sophisticated analytics that compare data from the metered-dose inhaler to the patient’s baseline and clinical guidelines. When data from the patient exceed normal fluctuations, the system alerts health care providers that the patient’s condition may not be under control and headed for another flare-up.

Propeller says the system also provides patients with more detailed coaching to help them keep to their prescribed medications with reminders and notifications. Coaching provided by the app also includes guidance on improving the patient’s inhaler technique, which the company says is often a problem with inhaled medications.

FDA cleared the device under section 510(k) of the Food, Drug and Cosmetic Act that requires pre-market notification of intent to market a medical device. Pre-market notification is required for new devices, or those like Propeller Health’s system that undergo significant change where safety or effectiveness could be affected.

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