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FDA grants clearance for Hologic’s cervical cancer screening system

February 2, 2024

The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for cervical cancer screening.

This system is claimed to be the first FDA-cleared digital cytology platform that integrates deep-learning-driven artificial intelligence (AI) with volumetric imaging technology.

The development marks a significant advancement in the detection of pre-cancerous lesions and cervical cancer cells.

The Genius Digital Diagnostics System revolutionises the traditional Pap test process by digitising the glass slides and applying an AI algorithm.

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