The TGA application for Airsonea is actually very interesting. As far as I’m aware there has not been a medical app approved through the TGA yet. This will be the first if it is to be assumed that the airsonea device approval is tied to the smartphone app.
Very difficult to pick. There has been a perception that the TGA has gone slow in this area to leave it to the FDA to work things out. But now they will have decide on an application using the standard medical device criteria that don’t quite fit for this combination device.
You would take a guess that it should get through but I suspect no one knows.
Caught up with a colleague who attended the conference. Not a great report. Their booth attracted interest but it was staffed by a pushy salesman. The app he demonstrated showed medications not available in Australia which was felt would just confuse patients so lost the audience a bit.
But the main mistake was thinking that someone like a Pead Asthma specialist at a major teaching hospital is actually going to start buying medical devices from pushy salesman. I think it was the Wheezometer they were trying flog – but I’m not sure. Marketing 101 failure I’m afraid.
Anyway the Australian National Asthma Council has just released their Iphone app (Asthma buddy). Designed to be consistent with the new guidelines which are moving away from PER and symptom severity monitoring and more to plans etc. That’s where the major interest was.
A long road ahead is my gut feeling.
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