iSonea gets TGA listing for AirSonea

iSonea (ASX:ISN) has secured Australian regulatory approval for its AirSonea wheeze-monitoring device.

The product has been cleared for listing on the TGA’s Australian Register of Therapeutic Goods (ARTG).

iSonea CEO Michael Thomas said the ARTG listing was the final key milestone in the lead-up to the launch of AirSonea in Australia next month. “We look forward to bringing this important technology to market in September,” he said.

The AirSonea device uses iSonea’s Acoustic Respiratory Monitoring (ARM) technology to detect and monitor wheezes.

It will allow for wheeze-rate monitoring via smartphones and allow patients to share their results with medical practitioners via iSonea’s new cloud-based analytical system, AsthmaSense Cloud.

In June, iSonea chose Hong Kong-based Refined Manufacturing to be its manufacturing partner for the launch. A month later, the company completed a $13.5 million placement to raise funds for the market debut.

iSonea shares were trading 7% higher at $0.642 as of around 1 pm on Tuesday.