07 August 2013 | Regulatory | By BioSpectrum Bureau
Australia's TGA gives nod for iSonea's AirSonea wheeze detection and monitoring device
Singapore: Medical technology company iSonea received approval from Australia's Therapeutic Goods Administration (TGA) to list its innovative product, the AirSonea wheeze detection and monitoring device.
This listing on the Australian Register of Therapeutic Goods (ARTG) is a critical company milestone as it prepares to launch the device for the first time in Australia next month. The device will enable wheeze rate monitoring via smartphones and a cloud-based analytical system.
Mr Michael Thomas, CEO, iSonea, said that the TGA listing provided further validation of the company's technology, as well as the Acoustic Respiratory Monitoring (ARM) platform underpinning all iSonea products.
He further said, "Inclusion on the TGA register is an important step for our Company as we complete the final stages of commercial launch preparation. We look forward to bringing this important technology to market in September that will change the way millions of asthmatics around the world can manage and monitor their breathing symptoms."