Over 100 AI-enabled radiology algorithms added to FDA's list of approvals

The U.S. Food and Drug Administration has added over 100 new artificial intelligence-enabled tools targeting radiology to its list of approvals since the start of the year. 

The agency updated its publicly available list of AI devices July 10, the first time since the start of 2025. The updated list contains 146 newly approved AI devices and, as usual, algorithms tailored to radiology lead the way. 

There have been an additional 115 radiology AI algorithms approved since Jan. 1, bringing the total number of these specific algorithms to 873 and making imaging the most prominent target of AI developers. However, many of the cleared algorithms in the categories of cardiology, neurology and orthopedics also are imaging specific, which would likely bring the total number of such approvals to more than 1,000. 

Notable companies that have earned recent approvals include Aidoc, Hyperfine, Clairity, GE HealthCare, Philips, Fujifilm, Canon Medical Systems, and Annalise.AI, among others. 

The amount of approved clinical AI applications has skyrocketed 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 year. It has since doubled. 

Although reimbursement for the use of AI in radiology is lagging, the potential for payment has shown signs of life recently. In October, the Centers for Medicare and Medicaid Services (CMS) updated its payment policies related to the use of AI-enabled platforms that assist with assessing CCTA exams, determining that AI coronary plaque assessments are “considered reasonable and medically necessary as a diagnostic study when the patient is eligible for CCTA.”  

Just a handful of AI applications are currently eligible for reimbursement, but many experts in the field have signaled that payment will eventually follow implementation. 

The full list of approved AI algorithms can be viewed here.