The U.S. FDA has compiled a comprehensive list of artificial intelligence/machine learning-enabled medical devices marketed in the U.S. to enhance public awareness. This initiative aims to provide valuable insights into the FDA’s ongoing efforts to ensure the safety and effectiveness of these devices while fostering transparency within the healthcare community.
The application of artificial intelligence and machine learning in medical devices has witnessed substantial growth, driven in part by developments in large language models, or LLMs. These LLMs, including models like ChatGPT and Llama, have fueled advancements across various fields of medicine by leveraging vast amounts of healthcare data, the FDA says.
As of October 19, the FDA has reviewed and authorized various AI/ML devices across medical disciplines. They have not yet authorized generative AI, artificial general intelligence, or large language model-powered devices.
This list, organized by Date of Final Decision, helps the public understand the presence of AI/ML medical devices in healthcare. These devices meet the FDA’s rigorous premarket requirements, ensuring their safety and effectiveness for their intended use.
Key insights from the list highlight significant trends:
- The year-over-year increase of AI/ML-enabled devices slowed in 2021 (15%) and 2022 (14%), following a 39% increase in 2020.
- Radiology dominates with 87% of devices authorized in 2022, followed by cardiovascular at 7%.
- Radiology maintains its leading position, with 79% of devices authorized through July 2023.
- Hybrid machine learning models combining different algorithmic approaches are increasingly popular for building safe and effective devices.
The FDA plans to periodically update this list to reflect the evolving landscape of AI/ML-enabled medical devices, ensuring that the public remains informed about the latest developments in this rapidly advancing field.
