FDA’s AI Medical Device Approvals

In recent years, FDA has approved a number of pieces of software that use artificial intelligence (AI) under its medical device approval system. FDA approved only 5 AI-power medical devices in 2015, but approved 115 of these in 2021 and likely will approve even more in 2022.

Which companies are the ones with the most AI-power medical devices that were granted FDA approval this year (2022) so far? An interesting blog post by Joel Selanikio finds that large industry incumbents are the ones who are getting the most AI-related medical device approvals this year.

While we do see a number of new companies getting approval, industry incumbents have the advantage of larger data sets and the ability to spread the relatively fixed cost of AI development across more product types. Nevertheless, there are certainly opportunities for young start-ups to get in on the AI healthcare market as well.