Let's be clear - this is not a medical device and is not presented or marketed as such. Software / apps definitely can be medical devices (SaMD) and if it was u

Let's be clear - this is not a medical device and is not presented or marketed as such. Software / apps definitely can be medical devices (SaMD) and if it was used in someone with impaired lung function for whatever reason, or replicated the functionality of incentive spirometers then it would be regulated as such. The medical device version of the app will be a separate app, initially for asthma and COPD, and will have other features specific to these conditions. There is lots of functionality that can be added - compliance, medication tracking, physical activity, educational modules that you don't get with a 10$ spirometer. This health version will be a Class I medical device and we will publish the results of any trials with peer review. Lungy is currently an app for people with healthy lungs - breathing exercises and mindfulness are effective at reducing anxiety and stress symptoms.