Signify Premium Insight: Trends in Medical Imaging AI Approvals

Published: April 1, 2021

One of the milestones any innovation in healthcare must pass is that of regulatory clearance, and medical imaging AI solutions are no exception. Regulatory clearance is an essential part of a solution’s progression from an idea to a commercially available product, as such, Signify Research’s Regulatory Approvals for Medical Imaging AI database reveals illuminating trends within the market.

For example, the number of clearances was very small before 2018 and these were primarily in the US (US-FDA) and Europe (CE Mark). There was a slight upward trend over the preceding years, but the change was very gradual and quite minor. Then in 2018, there was a sudden and significant increase in the number of regulatory clearances, as seen in Figures 1 and 2. This rapid expansion could be a result of several factors. Firstly, deep learning technology itself,



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