Great point. The devices do not change in efficacy across borders but the regulatory system that monitors safety and effectiveness certainly does between the US

Great point. The devices do not change in efficacy across borders but the regulatory system that monitors safety and effectiveness certainly does between the US, EU, and East Asia, for example. And we're (the US) at the bottom of that assessment. As for tracking direct patient outcomes, take a look here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc... the fda is actually creating something really really awesome but the question after is the applications and how (tech-wise, what's powering the mediums through which multiple applications are implemented?) So we aim to be in those conversations.