ARADIGM'S SMARTMIST ASTHMA MANAGEMENT SYSTEM 501(K)
This article was originally published in The Gray Sheet
Executive Summary
ARADIGM'S SMARTMIST ASTHMA MANAGEMENT SYSTEM 501(K) application is slated for submission in late 1995, according to the firm, which was formerly called MIRIS Medical. SmartMist is a hand-held, microprocessor-controlled pulmonary drug delivery system that is preprogrammed to actuate a metered dose inhaler (MDI) at the moment the patient's inhalation reaches the proper rate and volume. SmartMist also can record the time, date and "respiration parameters" each time the patient uses the device. Physicians can access this information with optional computer software.