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FDA adds 128 AI-enabled radiology-focused devices to its approval list

The U.S. Food and Drug Administration just updated its list of approved artificial intelligence- and machine learning-enabled medical devices, the majority of which are tailored to the radiology space.

On May 13, FDA added an additional 191 AI/ML-enabled devices to the list, bringing the total to 882. In line with prior trends, radiology once again accounted for the bulk of the approvals—of the newly added items, 128 are radiology focused.

“The FDA is providing this list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area,” the update reads. “The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.”

Siemens Medical Solutions, GE, Philips, Canon,, Butterfly Network, Lunit and Aidoc Medical are among some of the notable companies to land on the list, along with numerous others.

Of the newly cleared devices, 151 were approved between August 1, 2023, and March 31, 2024, while another 40 were from prior periods and were approved after further refinement methods, FDA shared.

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 that same year, nearly 200 more were added to the approvals list.

Radiology is a field where many believe AI/ML can make the most immediate clinical impact. That is reflected in the amount of radiology applications featured on the list—almost 80% of all approved AI medical devices are related to medical imaging in some way.

However, FDA clearance does not necessarily equate to insurance coverage when AI products are utilized by providers. Currently, the Centers for Medicare & Medicaid Services (CMS) has assigned payment for just around 10 of these devices.

This is an issue that multiple medical organizations and patient advocacy groups are actively lobbying to change. On Monday, more than a dozen of these groups sent a letter to leaders of the congressional bodies that oversee appropriations in the Senate and House urging them to define a pathway for CMS to cover the use of AI in medical settings. Health Imaging

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