FDA Classifies AI-Powered Digital Cervical Cytology Slide Imaging System

The U.S. Food and Drug Administration (FDA) has classified the digital cervical cytology slide imaging system with an artificial intelligence (AI) algorithm into Class II (special controls). This regulatory action, effective November 5, 2026, aims to ensure the safety and effectiveness of this medical device used in hematology and pathology for cervical cytology. The classification includes specific controls related to design verification, validation, risk mitigation analysis, and labeling.