In the previous issue of The Imaging Wire, we discovered how venture capital investment in AI developers is fueling rapid growth in new AI applications for radiologists (despite a slowdown this year).
This trend was underscored late last week with new data from the FDA showing strong growth in the number of regulatory authorizations of AI and machine learning-enabled devices in calendar 2023 compared to the year before. The findings show:
- A resurgence of AI/ML authorizations this year, with over 30% growth compared to 14% in 2022 and 15% in 2021 – The last time authorizations grew this fast was in 2020 (+39%)
- The FDA authorized 171 AI/ML-enabled devices in the past year. Of the total, 155 had final decision dates between August 1, 2022 to July 30, 2023, while 16 were reclassifications from prior periods
- Devices intended for radiology made up 79% of the total (122/155), an impressive number but down slightly compared to 87% in 2022
- Other medical specialities include cardiology (9%), neurology (5%), and gastroenterology/urology (4%)
One interesting wrinkle in the report was the fact that despite all the buzz around large language models for generative AI, the FDA has yet to authorize a device that uses generative AI or that is powered by LLMs.
The Takeaway
The FDA’s new report confirms that radiology AI shows no sign of slowing down, despite a drop in AI investment this year.
The data also offer perspective on a JACR report last week predicting that by 2035 radiology could be seeing 350 new AI/ML product approvals for the year. Product approvals would only have to grow at about a 10% annual rate to hit that number – a figure that seems perfectly achievable given the new FDA report.
