AI-Powered & FDA-Approved Medical Health Projects

In July 2017 the US FDA (Food and Drug Administration) launched its Digital Health Innovation Action Plan to provide Americans "timely access to safe and effective digital health products," many of which are being developed using artificial intelligence technologies. A key component of the Digital Health Innovation Action Plan is the innovative Software Precertification (Pre-Cert) Pilot Program, which a number of AI-based digital health projects have already completed, spiking FDA AI Med approvals in 2018. Synced takes a look at some of these companies and their FDA 510(K) clearance and Premarket Approval (PMA) AI-empowered medical product innovations. IDx is a technology company applying AI in medical diagnostics. In April 2018 the company received FDA premarket approval (PMA) for its product IDx-DR, an AI diagnostic system that detects signs of diabetic retinopathy in retinal images.