The state of Artificial Intelligence in Healthcare in the US

A new article in Nature entitled The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database presents the first comprehensive and open access database of strictly AI/ML-based medical technologies that have been approved by the FDA, the US Food and Drug Administration.

Impact of Regulation

The authors of this article explain that the FDA is in forefront when it comes to regulatory approval of Artificial Intelligence based medical technologies. However, some significant regulatory hurdles are present.

Whereas the FDA is usually approving technologies based on 'locked' algorithms, the reality of algorithm development is that algorithms are 'adaptative', i.e they can improve over time, for example thanks to more data and new retraining.

A comprehensive database of AI based devices and solutions

The article explains that the authors have developed a database of 64 medical devices and algorithms that are based on Artificial Intelligence/Machine Learning and have been FDA-approved. However, out of these 64, only 29 devices meet the criteria of being considered an AI/ML-based technology in the related official FDA announcements.

Main medical disciplines in the database

These 29 devices can be clustered in 2 groups :

• The two main medical specialties using Artificial Intelligence technology are Radiology and Cardiology.
• The other applications focus on internal medicine/endocrinology, neurology, ophthalmology, emergency medicine, and oncology.

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