US Experience: FDA-Approved AI Devices – 1,200+ Authorizations, Critical Evidence Gaps

Key Points

• The aim is to examine the landscape of FDA-approved AI devices and identify critical evidence gaps.
• Data analysis of over 1,200 authorized AI devices
• Review of regulatory documentation and guidelines
• Assessment of reported evidence supporting device efficacy
• Identified numerous critical gaps in supporting evidence for safety and effectiveness
• Highlighted inconsistencies in the regulatory framework for AI device authorizations
• Demonstrated a rapid increase in the number of AI device approvals over recent years