Hologic Unveils the First and Only FDA-Cleared Digital Cytology System

Hologic broadens its history of innovation with the GeniusTM Digital Diagnostics System, an AI-powered digital cytology solution poised to strengthen the fight against cervical cancer.

Hologic's revolutionary digital cytology platform - the Genius™ Digital Diagnostics System - has been granted marketing authorization from the U.S. Food and Drug Administration (FDA). 

The innovative system will help advance cervical cancer screening by providing more accurate disease detection than manual and image-guided cytology review, streamlining operational and screening efficiency, and supporting the field of cytology through innovation.1 

"Hologic is a leading innovator in women’s health with a commitment to advancing cervical and breast cancer screening technologies, from the first liquid-based cytology test to the first 3D mammography system and now the first FDA-cleared digital cytology platform," said Jennifer Schneiders, Ph.D., Division President, Diagnostic Solutions at Hologic. "Our technologies have had a tremendous impact on decreasing cancer rates in women, and we are incredibly excited by the promise of Genius Digital Diagnostics. The system delivers more actionable and accurate insights for laboratories and healthcare professionals to enhance patient care."

Genius Digital Diagnostics utilizes advanced volumetric imaging technology to convert glass ThinPrep® Pap test slides into digital images with exceptional clarity. Harnessing novel artificial intelligence (AI), it then helps identify pre-cancerous lesions and cervical cancer cells with seamless, digital precision resulting in hands-free case management and optimized review. 

The arrival of Genius Digital Diagnostics ushers in the next generation of cytology technology, promising a future of improved outcomes for women lies ahead.1 We look forward to continuing our mission to deliver world class products that not only exemplify the Science of Sure but also help provide superior care to patients everywhere, every day.

View Press Release here.

    1. Genius Digital Diagnostic Systems. Instructions for Use AW-23890-001. Hologic, Inc.; 2023