Dozens of new AI-powered devices make FDA's list of approvals
The U.S. Food and Drug Administration has added dozens of new artificial intelligence-powered radiology tools to its list of approved devices.
Alongside a handful of other approvals in areas such as cardiology and neurology, the list, which was updated during the first week of December, now contains over 1,300 AI-enabled medical devices.
Products targeting radiology continue to dominate the agency’s approval list. The addition of 56 new radiology-specific devices brings the total number of such tools approved for use in clinical imaging settings to 1,039. These account for nearly 80% of the FDA’s entire list of approved devices to date.
The list contains all devices that were approved between mid-July and the end of September. It includes many familiar names, such as GE HealthCare, Siemens Medical Solutions, Fujifilm, Qure.ai, DeepHealth and more.
AI has come a long way since the first approval in the late '90s, skyrocketing in recent years. At the beginning of 2023, there were around 500 approvals, but more than 200 were added to the list by the end of that same year. It has since more than doubled.
These developments were evident recently on the show floor during the annual meeting of the Radiological Society of North America. There were over 200 AI vendors with booths at the conference, more than 100 of which were among those displaying at the AI Showcase.
The emergence of AI also is on the top of President Trump’s mind as of late. This most recent update preceded a move from the White House intended to accelerate the use of medical AI. Last week, President Trump issued an executive order aimed at curbing states’ “excessive” regulations tied to the technology. President Trump cautioned that such overreach by states threatens to “undermine this major growth engine,” which he says helps “make the U.S. economy the hottest in the world.” It is likely, however, that the order will face legal challenges.
The full list of the FDA’s AI approvals can be found here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.