Respiri Limited (ASX:RSH) has achieved TGA approval to list its wheezo asthma monitoring device (pictured) on the Australian Therapeutics Goods Register (ARTG).
The device is the world’s first digital wheeze monitoring solution of sensor, smartphone application and digital health platform to help people manage respiratory disease.
TGA approval came after the Melbourne company undertook an audit of its Quality Management System to achieve the ISO 13485 certification required for medical device manufacturers.
This also triggered approval for a CE mark, which will allow sale within the European Union.
With 43 million asthma sufferers in the two regions, the approvals open up big markets for the company’s over-the-counter monitoring solution.
wheezo provides sufferers with an effective portable tool to help better manage their condition.
Respiri chairman Nicholas Smedley said: “With this regulatory step completed, we are now at the point of commercialisation, with focus on our go to market strategy to make tis innovative monitoring solution available to people with asthma as soon as possible.”
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