FDA adds dozens of AI-enabled radiology applications to list of clearances
Dozens of new artificial intelligence and machine learning-enabled medical products have been added to the U.S. Food and Drug Administration’s list of approved clinical AI applications, bringing the total number of cleared AI offerings to 950.
The latest update includes the addition of 61 new approvals. Similar to past updates, applications catered to radiology account for the majority of the new clearances, with 44 products landing on the list since the end of March.
With 723 FDA-cleared algorithms, AI applications tailored to radiology make up over 70% of all approved products. Next in line are applications that target the cardiology space, with 98 cleared algorithms. Neurology sits in a distant third, with 34 products. The rest of the product approvals are scattered throughout other medical specialties.
The FDA has increased its efforts to update developments within the AI space. Previously, the agency would update its list of cleared AI-enabled devices maybe once per year, but with new AI technology gaining approvals more often, the agency has increased the frequency of its updates. The latest list contains products that were approved between March 31 and June 25.
The amount of AI/ML medical devices approved by the FDA has grown exponentially in recent years. At the start of 2023, that number sat near 500, but by the end of the same year, nearly 200 more were added to the approvals list.
Insurance reimbursement for AI utilization, however, is not keeping pace with the number of approved applications. Currently, the Centers for Medicare & Medicaid Services (CMS) has assigned payment for just around 11 devices, but that number is expected to grow.
The lack of reimbursement has not prevented providers from embracing the technology. At this year’s Society for Imaging Informatics in Medicine (SIIM) annual conference, numerous radiologists shared that they had already implemented some sort of AI application into their own practice, many of them expressing optimism for more widespread reimbursement in the future.
The full list of the FDA’s cleared AI-enabled devices 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 joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.