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Hologic wins FDA approval for AI-enabled cervical cancer screening system

Hologic has gained regulatory approval to sell an AI-powered cervical cancer screening system in the U.S. Named the Genius Digital Diagnostics System, it digitizes Pap test slides and employs AI to identify cells needing review by cytologists and pathologists.

This clearance follows BD's collaboration with Techcyte for an AI-driven cervical cancer screening test. Despite the sensitivity of human papillomavirus assays, Pap smears persist due to interpretation variability among pathologists.

Hologic's system digitizes slides and uses AI to flag cells for further review, allowing staff to focus on potentially cancerous cells, facilitate remote viewing, and enable collaborative assessment. According to Hologic, a study found a "28% reduction in false negatives of high-grade squamous intraepithelial and more severe lesions compared to microscopic review," potentially enhancing cancer detection rates.