Among the newly deleted devices, 151 were approved between August 1, 2023 and March 31, 2024, while 40 others came from previous periods and were approved after other refinement methods, shared the FDA.
The amount of AI / ML medical devices approved by the FDA has increased exponentially in recent years. At the beginning of 2023, this number was almost 500, but at the end of the same year, nearly 200 others were added to the list of approvals.
Radiology is an area where many believe that AI / ML can have the most immediate clinical impact. This is reflected in the amount of radiology applications appearing on the list – 80% of all APP medical devices are linked to medical imaging in one way or another.
However, the release of the FDA does not necessarily equivalent to insurance coverage when AI products are used by providers. Currently, the Centers for Medicare & Medicaid Services (CMS) have awarded payment for around 10 of these devices.
This is a problem that several medical organizations and patient defense groups make lobbying to change. On Monday, more than a dozen of these groups sent a letter to the leaders of the Congress organizations who supervise Cover the use of AI in medical environments.