iSonea wins CE Mark for AirSonea
iSonea (ASX:ISN) has secured CE Mark approval of AirSonea, its portable wheeze monitoring device for asthma patients.
The company has received the ISO safety, performance and electromagnetic compatibility certificates required for a CE Mark.
The certificates were awarded following testing by the Standards Institute of Israel (SII) and the Electronics and Telematics Laboratory (ETL).
“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,” iSonea CEO Michael Thomas said.
He called the ISO certification and CE Mark “an important step in certifying [AirSonea’s] readiness for sale in key international markets”.
Thomas said the company is now evaluating market opportunities for an entry into the EU market.
iSonea plans to launch the device first in Australia this month, having received TGA approval for the product in August.
iSonea expects to be able to launch in the US in 2014. The EU market debut will likely follow the anticipated US launch.
The company raised $13.5 million to support the market launch of AirSonea during a placement conducted in July.
iSonea (ASX:ISN) shares were trading 1.61% higher at $0.63 as of around 3 pm on Friday.
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