Revisited: FDA's AI Medical Device Approvals

About a year ago, I dug into FDA’s newly-released list of its AI medical device approvals. In that post, I noted some surprising findings: AI approvals were (1) becoming more concentrated, with a small group of companies winning a large percentage of the approvals, and (2) most approvals were going to established medical device titans, like Siemens and GE, rather than to startups. Both findings showing that AI in medicine was providing sustaining innovation for established companies more than disrupting the established ecosystem. With this release, I wanted to see if my earlier findings still held, how fast innovation was accelerating, how quickly were more companies getting involved — and what other surprises lay within the data.

blogJoel SelanikioOctober 30, 2023AI, FDA, medical device

A Closer Look at FDA's AI Medical Device Approvals

FDA recently added almost 200 new AI medical devices to its approved list. What does a closer look at the list tell us about advances in AI, and who is making them?

blogJoel SelanikioOctober 12, 2022disruption, FDA, regulation Comment