From: Engineering.com
Engineering Better Diabetes Care
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“I spent 18 years in wireless and helped build the telematics and wireless industries. In the meantime, I developed Type 2 diabetes myself and joined WellDoc in 2007. We were the first to develop software like developing a drug,” said Iyer.
“We did clinical trials, and published in peer-reviewed journals just like a pharmaceutical company would. We achieved FDA clearance, the first real-time coaching mobile app to do so. It actually carries a drug code, so to activate the app once you’ve downloaded it, you may need a prescription from your doctor. I’m involved, along with the FDA, in an organization called the IMDRF (the International Medical Device Regulators Forum) and we recently released a document about what developers need to do differently to create software that is treated as a medical device.”
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