The FDA has updated its list of AI- and machine learning-enabled medical devices that have received regulatory authorization. The list is a closely watched barometer of the health of the AI sector, and the update shows the FDA is keeping a brisk pace of authorizations.
The FDA has maintained double-digit growth of AI authorizations for the last several years, a pace that reflects the growing number of submissions it’s getting from AI developers.
- Indeed, data compiled by regulatory expert Bradley Merrill Thompson show how the number of FDA authorizations has been growing rapidly since the dawn of the medical AI era in around 2016 (see also our article on AI safety below).
The new FDA numbers show that …
- The FDA has now authorized 950 AI/ML-enabled devices since it began keeping track
- Device authorizations are up 15% for the first half of 2024 compared to the same period the year before (107 vs. 93)
- The pace could grow even faster in late 2024 – in 2023, FDA in the second half authorized 126 devices, up 35% over the first half
- At that pace, the FDA should hit just over 250 total authorizations in 2024
- This would represent 14% growth over 220 authorizations in 2023, and compares to growth of 14% in 2022 and 15% in 2021
- As with past updates, radiology makes up the lion’s share of AI/ML authorizations, but had a 73% share in the first half, down from 80% for all of 2023
- Siemens Healthineers led in all H1 2024 clearances with 11, bringing its total to 70 (66 for Siemens and four for Varian). GE HealthCare remains the leader with 80 total clearances after adding three in H1 2024 (GE’s total includes companies it has acquired, like Caption Health and MIM Software). There’s a big drop off after GE and Siemens, including Canon Medical (30), Aidoc (24), and Philips (24).
The FDA’s list includes both software-only algorithms as well as hardware devices like scanners that have built-in AI capabilities, such as a mobile X-ray unit that can alert users to emergent conditions.
- Indeed, many of the authorizations on the FDA’s list are for updated versions of already-cleared products rather than brand-new solutions – a trend that tends to inflate radiology’s share of approvals.
The Takeaway
The new FDA numbers on AI/ML regulatory authorizations are significant not only for revealing the growth in approvals, but also because the agency appears to be releasing the updates more frequently – perhaps a sign it is practicing what it preaches when it comes to AI openness and transparency.
