Uscom Commsec Executive Series, page-3

And I would like to see some more movement on the US front. I thought we had approval for both but it seems some further reg hurdles. Perhaps this will speed things up:

The new FDA draft guidance, “Use of Real-World Evidence to Support Regulatory DecisionMaking for Medical Devices” allows manufactures of medical devices to use Real-World Evidence (RWE) to support their application for submission to FDA for clearance and/or approval. RWE refers to evidence of a product’s performance and outcomes in settings outside of clinical trials, such as in hospitals, doctors’ offices, and patients’ homes. The new FDA draft guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum ents/UCM513027.pdf