SEVERNA PARK, Md., Oct. 3, 2012 /PRNewswire/ -- Medical technology company iSonea Ltd. (ASX: ISN; OTCQX: ISOAD) today announced that it submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) on Thursday, September 27, to market the SonoSentry, a rebranded non-prescription version of its personal Wheezometer, over the counter to consumers.
Like the Wheezometer, the SonoSentry measures a person's wheeze, a principal symptom of asthma. Using iSonea's proprietary Acoustic Respiratory Monitoring (ARM) technology, SonoSentry calculates a WheezeRATE, the percentage of breathing time spent wheezing.
"Having the SonoSentry available over-the-counter will make our unique ARM technology more broadly accessible," said Michael J. Thomas, CEO of iSonea Ltd. "The SonoSentry provides an objective measurement of wheezing and can help asthmatics to monitor this symptom more accurately and easily."
Once the filing is officially accepted by the agency, the typical review period is 90 days.
About iSonea Limited
iSonea Limited (ASX: ISN; OTCQX: ISOAD) is an emerging medical technology company developing innovative, non-invasive devices and mobile health apps to improve the management of chronic, costly respiratory disorders such as asthma and COPD. By leveraging iSonea's proprietary Acoustic Respiratory Monitoring (ARM) technology with its AsthmaSense mobile applications, iSonea is turning smartphones into medical devicesenabling anyone, anywhere, at any time to monitor breathing distress symptoms, in order to take action. iSonea's ARM devices have been cleared for use by the U.S. Food and Drug Administration, the Australian TGA and the European Union CE. For more information, please visit www.SoundAsthma.com.
Forward Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on iSonea's current expectations, estimates and projections about the industry in which iSonea operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," "guidance" and similar expressions are intended to identify forward-looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of iSonea, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. iSonea cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of iSonea only as of the date of this release. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. iSonea will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
SOURCE iSonea Limited