The U.S. Food and Drug Administration (FDA) has announced a significant update to its list of approved artificial intelligence (AI) and machine learning (ML) enabled medical devices, with a notable emphasis on applications within the field of radiology. On May 13, the FDA added 191 new devices to the list, bringing the total number of approved AI/ML-enabled medical devices to 882.

In accordance with established trends, radiology accounted for the majority of the newly approved devices. Of the 191 additions, 128 are focused on radiology, reflecting the widespread belief that AI/ML technology can have the most immediate clinical impact in this area.

“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 stated. “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.”

Notable companies that have secured FDA approvals for their AI/ML-enabled devices include industry leaders such as Siemens Medical Solutions, GE, Philips, Canon, Viz.ai, Butterfly Network, Lunit, and Aidoc Medical, among others.

Of the newly cleared devices, 151 were approved between August 1, 2023, and March 31, 2024. An additional 40 devices from prior periods were also approved following further refinement methods, as detailed by the FDA.

The exponential growth in the number of FDA-approved AI/ML medical devices is noteworthy. At the beginning of 2023, the number of such devices was near 500. By the end of that same year, nearly 200 more devices had been added to the list, indicating a rapid acceleration in the development and approval of these technologies.

Nearly 80% of all approved AI medical devices are related to medical imaging, underscoring the significant role AI/ML is expected to play in enhancing radiological diagnostics and workflows. However, despite FDA clearance, insurance coverage for these devices remains limited. Currently, the Centers for Medicare & Medicaid Services (CMS) has approved payment for only about 10 AI/ML-enabled devices.

This gap between FDA approval and CMS coverage has prompted action from multiple medical organizations and patient advocacy groups. On Monday, over a dozen such groups sent a letter to congressional leaders overseeing appropriations in both the Senate and the House, urging them to establish a clear pathway for CMS to cover the use of AI in medical settings.

As AI and ML technologies continue to advance and integrate into medical practice, the FDA’s expanded list serves as a crucial resource, providing transparency and assurance regarding the safety and effectiveness of these innovative devices. However, the ongoing efforts to secure broader insurance coverage highlight the need for continued advocacy and policy development to fully realize the potential benefits of AI/ML in healthcare.