FDA authorizations of medical AI devices are going up again.

The FDA has been adding more and more AI-enabled medical devices to its roster of authorized products this year. Last month, an update with 171 new products added a boost to the pool of these devices, the numbers of which had stagnated a bit due to the COVID-19 pandemic. This growth indicates a positive sign that AI devices are standing the test of regulatory bodies. Even as questions about future rounds of regulation—especially for generative AI—linger.

Chart: MedTech Pulse
Chart: MedTech Pulse

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