iSonea has filed an over-the-counter version of a new asthma monitoring device's 510(k) application with the US Food and Drug Administration (FDA) for approval.
SonoSentry, which is a rebranded non-prescription version of personal Wheezometer, measures patients wheeze, which is a principal symptom of asthma.
Using the company’s proprietary acoustic respiratory monitoring (ARM) technology, the device will calculate percentage of breathing time spent wheezing as note it as WheezeRATE.
iSonea CEO Michael Thomas said the SonoSentry provides an objective measurement of wheezing and can help asthmatics to monitor the symptom more accurately and easily.
"Having the SonoSentry available over-the-counter will make our unique ARM technology more broadly accessible," Thomas added.
The company anticipates that the FDA agency will take a time period of 90 days for review.