FDA-Cleared AI Primary Screening Systems Already Deployed
#1Hologic's ThinPrep Imaging System received FDA clearance in 2003 and has been in commercial deployment for over two decades, with the current TIS 5000 generation processing slides in high-volume reference labs at scale. BD FocalPoint received clearance in 2008 and enables archiving up to 25% of slides without cytotechnologist review. More critically, regulatory submissions for expanded AI primary screening autonomy — permitting 'No Further Review' decisions on a higher percentage of slides — are actively advancing. In 2023-2024, Hologic expanded TIS clearance parameters, and international markets (UK NHS, Dutch population screening programs) have already deployed AI as the primary screener with cytotechnologist review only of AI-flagged cases.