Food and Drug Administration (FDA)

4 Posts

Chart showing the number of AI/ML devices approved by FDA by year from 2012 to 2023
Food and Drug Administration (FDA)

Doctors Wary of Medical AI Devices: U.S. regulatory system criticized for approving AI medical devices without transparency.

The United States’ regulatory regime may not be clear or flexible enough to ensure the safety of AI-powered medical devices. Physicians and other health professionals believe that U.S. regulators have approved AI-powered medical products without proper oversight or disclosure.
Doctor checking a monitor inside an OR
Food and Drug Administration (FDA)

New Clarity on Rules for Medical AI: FDA Guidance on AI Medical Devices for 2022

The United States paved the way to regulate AI systems in healthcare. The U.S. Food and Drug Administration (FDA) interpreted existing rules that govern health-related software to include some machine learning algorithms.
Series of images showing a variety of medical AI products
Food and Drug Administration (FDA)

Medical AI’s Hidden Data: Why many medical AI devices are black boxes.

U.S. government approval of medical AI products is on the upswing — but information about how such systems were built is largely unavailable. The U.S. Food and Drug Administration (FDA) has approved a a plethora of AI-driven medical systems.
Doctor examining a snowman holding a broom
Food and Drug Administration (FDA)

The Model Will See You Now: The rise of medical AI in 2020

Institutional hurdles to AI for medicine began to fall, setting the stage for widespread clinical use of deep learning in medical devices and treatments. DeepMind’s AlphaFold model determined the three-dimensional shape of a protein in just hours.

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