In recent years, the FDA has approved several software using artificial intelligence (AI) under its medical device approval system. The FDA approved only 5 AI medical devices in 2015, but approved 115 of them in 2021 and may approve more in 2022.
Which companies have the most AI medical devices approved by the FDA so far?an interesting Blog post by Joel Selanikio Large industry incumbents were found to have received the most AI-related medical device approvals this year.
While we do see many new companies approved, industry incumbents have the advantage of larger datasets and the ability to spread relatively fixed AI development costs across more product types. Still, there are certainly opportunities for young startups to enter the AI healthcare market.
