MedTech Dive October 9, 2024
The FDA authorized nearly 1,000 medical devices with artificial intelligence features between 1995 and Aug. 7, 2024.
The number of medical devices with artificial intelligence technology has risen sharply in the past decade.
The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices as of Aug. 7, 2024, according to the agency’s database. While the FDA authorized the first AI-enabled device in 1995, the number of submissions has spiked in recent years.
In 2015, the FDA authorized six AI medical devices. In 2023, the agency authorized 221 devices, according to data reviewed by MedTech Dive.
The trend has been driven by more connected devices, more investment into AI and machine learning and growing familiarity with how...
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