FDA Approves First Full Home-Use Wireless Spirometer

GoSpiro Home Spirometer, the first wireless spirometer developed for home use, has received clearance from the US Food and Drug Administration (FDA) for the management of respiratory diseases such as chronic obstructive pulmonary disease and asthma. Currently, it is the only product on the market that meets both the ISO and FDA requirements for home-use devices.
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The device collects diagnostic quality forced spirometry and slow spirometry, and was found to have the same accuracy as hospital laboratory systems.

In addition, the wireless spirometry was designed to work with a wide range of smartphones, tablets, and PCs, and seamlessly integrates with Monitored Therapeutics’ GoHome Patient Health Monitor that collects and transmits data from patients and delivers physician’s instructions to the patients.

—Melissa Weiss

Reference:

FDA clears first full home-use spirometer with wireless connection [press release]. Dublin, OH: Monitored Therapeutics, Inc.; April 18, 2017. http://monitoredrx.net/wp-content/uploads/2014/11/Press-Release-GoSpiro-510k_F.pdf.