The FDA has authorized 882 AI or machine learning-enabled devices to date, according to their latest update of their listing. Radiology is still going strong covering 76% of this list. Cardiology and neurology are the second and third largest categories, but they trail far behind radiology.
Distribution of medical devices according to FDA database
However, we can expect other disciplines to catch up in the near future. In 2023, all other disciplines combined saw a doubling in the number of new devices brought to market compared to 2022. While the number of new products in radiology also increased in 2023, it did not do so to the same extent.
New products brought to market per year according to FDA database
Interestingly, in Europe, the growth of new CE-marked devices has drastically slowed down. We will be discussing this topic in an upcoming blog, so stay tuned!