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.

None identified

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.