iSonea asthma monitor gets CE Mark, no FDA yet

By Jonah Comstock

airsoneaiSonea, the Maryland-based startup working on smartphone-based asthma monitoring, says it will launch its AirSonea connected hardware device in Australia prior to launching in the US.

The company's AirSonea product, which builds on the company's previous device, the Wheezometer, uses a proprietary sensing method the company calls Acoustic Respiratory Monitoring to monitor an asthma patient's symptoms. The user places the sensor against his or her windpipe while breathing to use it.

"When used over time, ARM can give you a better understanding of how triggers such as pollen, pets, activity or anxiety may affect you," the company writes on its website. "It can let you know if your WheezeRATE is increasing, decreasing, or staying the same. It can also be used to measure the response of wheezing symptoms to medication use."

iSonea previously released an app, AsthmaSense, that allows users to manually record their symptoms. From its conception, the app was designed to eventually work with AirSonea, which at the time the company said was still awaiting over-the-counter 510(k) FDA clearance.

Neither the clearance nor the product has yet emerged, although the company has been speaking about FDA clearance since 2012, even inking a deal with Qualcomm to be part of its 2net hub. The postmarket clinical trial the company was talking up in March 2012 has been terminated as of last month. The company does hold an FDA clearance for their original non-smartphone connected Wheezometer, but it is only cleared for prescription use.

Now the company has announced that it has secured a CE Mark from the European Union and will be launching its device next month in Australia. Although the the company is now headquartered in Maryland, it was formed from a merger of two companies outside the US: Australian PulmoSonix and Israeli Karmelsonix. According to the release, the iSonea is "assessing market opportunities in the EU for possible entry, following an anticipated 2014 US launch."

This video, originally posted in March, shows how iSonea envisions the AirSonea and AsthmaSense app being used: