FDA Classifies AI-Powered Digital Cervical Cytology Slide Imaging System as Class II Medical Device

The U.S. Food and Drug Administration (FDA) has classified the digital cervical cytology slide imaging system, which incorporates an artificial intelligence algorithm, into Class II with special controls. This regulatory action, effective November 5, 2026, aims to ensure the device's safety and effectiveness while facilitating patient access to innovative diagnostic technologies for cervical cytology.