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First FDA-cleared digital cytology system.
February 5, 2024
By: Rachel Klemovitch
Assistant Editor
Hologic has announced its Genius Digital Diagnostics System with Genius Cervical AI algorithm has received FDA clearance. This marks the first and only FDA-cleared digital cytology system that combines and AI interface with advanced volumetric imaging technology to identify pre-cancerous lesion and cervical cancer cells. “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. 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,” said Diagnostic Solutions President, Jennifer Schneiders. Current screening for cervical cancer includes a Pap test, where a sample is collected transferred to a glass slide for review. The Genuis Digital Diagnostics System creates a digital image of the glass slide, and an artificial intelligence algorithm pinpoints the cells that cytologists and pathologists should review. The process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity. When compared to a microscopic review, there was a 28% reduction in false negatives of high-grade squamous intraepithelial and more severe lesions1. The Genius Digital Diagnostics System can help laboratories provide needed information to healthcare professionals for more effective and timely treatment decisions. The system also allows cytologists and pathologists to review cases remotely, so patients can benefit from geographically dispersed experts. The Genius Digital Diagnostics System consists of the Genius Digital Imager, Genius Cervical AI algorithm, Genius Image Management Server, and the Genius Review Station. The system is currently available in Europe, New Zealand, and Australia. Commercial availability in the US is expected in early 2024. Resources: 1 Genius Digital Diagnostics System with the Genius Cervical AI Algorithm Instructions for Use AW-23890-001. Hologic, Inc.; 2024
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