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  • eac25 replied to the topic LifeVest Wearable Cardioverter Defibrillator in the forum Introduction to Project Management 8 years, 4 months ago

    For the mobile application, if the only function of the application was to show the heart rate I believe it still would be subject to FDA regulation. It certainly would have an easier time passing FDA hurdles than if there was more functionality to it, such as if this app allowed the user to control the voltage of the electrodes and other important functionalities. Additionally, since the app is tied to this product, it still must undergo mobile medical application regulation.