The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
Overview
Paper Summary
The authors identified 64 FDA-approved medical devices and algorithms using AI/ML, with only 29 explicitly mentioning AI/ML in their official announcements. Radiology and Cardiology are the leading specialties for these technologies, and the authors created an open-access database to track and categorize these devices.
Explain Like I'm Five
Scientists found that many smart computer helpers are being used by doctors to look inside your body, especially hearts and bones. They made a special list of all the approved ones so everyone knows they're safe to use.
Possible Conflicts of Interest
None identified
Identified Limitations
Rating Explanation
This paper provides a valuable resource by creating a database of FDA-approved AI/ML-based medical devices and algorithms. While the methodology has limitations due to reliance on publicly available information and the FDA's website structure, the open-access database and its potential for community contributions represent a significant step towards greater transparency and understanding of AI/ML in healthcare. The focus on FDA approvals ensures a level of regulatory oversight and validity. It also appropriately highlights the challenges posed by the rapid growth of this technology and the limitations of current regulatory practices.
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