iSonea Gets a CE Mark for AirSonea
iSonea Achieves CE Mark for AirSonea™
Asthma Wheeze Monitor Conforms to Safety and Performance Standards
Melbourne Australia and Severna Park MD USA. — 4 September 2013 — Medical technology company iSonea Limited (ASX: ISN) announces that testing and technical documentation has been completed for the AirSonea Wheeze Monitor to receive the Conformité Européenneor CE Mark.
This step clears the way for AirSonea to be marketed in the 27 Member States of the European Union, as well as in the four Member States of the European Free Trade Association and in Turkey. After thorough testing, the Standards Institute of Israel (SII) and The Electronics and Telematics Laboratory (ETL) have certified that the AirSonea device conforms to the International Organisation for Standardisation (ISO) standards for safety and performance.
iSonea has received the following ISO safety, performance, and electromagnetic compatibility certificates for AirSonea:
• International Electrotechnical Commission (IEC) EN 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment);
• IEC EN 60601-1-2 (Electromagnetic compatibility requirements and tests for medical electrical equipment); and
• European Telecommunications Standards Institute (ETSI) EN 489-1 v1.9.2 (Electromagnetic compatibility standards for radio equipment and services).
“Attainment of these standards of safety and performance allows the Company to complete the technical file and issue a declaration of conformity with the CE,” said Michael Thomas, chief executive officer. “This is an important step in certifying the product’s readiness for sale in key international markets.”
iSonea plans to launch the AirSonea Wheeze Monitor in Australia in September 2013 and is assessing market opportunities in the EU for possible entry, following an anticipated 2014 US launch.
Mr Michael Thomas Emma Power Dr Stewart Washer
Chief Executive Officer Monsoon Communications Chairman
iSonea Limited +61 (0) 419 149 525 +61 (0) 418 288 212
+1 410-777-5251 firstname.lastname@example.org swasher@isoneaMed.com
About iSonea Limited
iSonea Limited (ASX:ISN) 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 smart phones into personal monitoring devices -- enabling anyone, anywhere, at any time to monitor asthma breathing symptoms. 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.iSoneaMed.com and 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.
Posted: September 2013