One year after analyzing FDA’s AI medical device approvals, a new dataset confirms: growth continues, but acceleration is absent. While more young companies are joining the field, older firms like GE still dominate approvals—classic sustaining innovation. And Big Tech? Still barely on the board.

FDA approvals of AI-enabled medical devices are accelerating—but not in the way you might expect. While new startups are entering the space, the real winners remain legacy giants like GE and Siemens. An analysis of the latest FDA data reveals a classic case of sustaining innovation, not disruption, as established players integrate AI to reinforce their dominance.