Is radiology’s AI edge fading, at least when it comes to its share of AI-enabled medical devices being granted regulatory authorization by the FDA? The latest year-to-date figures from the agency suggest that radiology’s AI dominance could be declining.
Radiology was one of the first medical specialties to go digital, and software developers have targeted the field for AI applications like image analysis and data reconstruction.
- Indeed, FDA data from recent years shows that radiology makes up the vast majority of agency authorizations for AI- and machine learning-enabled medical devices, ranging from 86% in 2020 and 2022 to 79% in 2023.
But in the new data, radiology devices made up only 73% of authorizations from January-March 2024. Other data points indicate that the FDA …
- Authorized 151 new devices since August 2023
- Reclassified as AI/ML-enabled 40 devices that were previously authorized
- Authorized a total of 882 devices since it began tracking the field
In an interesting wrinkle, many of the devices on the updated list are big-iron scanners that the FDA has decided to classify as AI/ML-enabled devices.
- These include CT and MRI scanners from Siemens Healthineers, ultrasound scanners from Philips and Canon Medical Systems, an MRI scanner from United Imaging, and the recently launched Butterfly iQ3 POCUS scanner.
The additions could be a sign that imaging OEMs increasingly are baking AI functionality into their products at a basic level, blurring the line between hardware and software.
The Takeaway
It should be no cause for panic that radiology’s share of AI/ML authorizations is declining as other medical specialties catch up to the discipline’s head start. The good news is that the FDA’s latest figures show how AI is becoming an integral part of medicine, in ways that clinicians may not even notice.
