Feb. 2, 2024—Hologic announced that its Genius Digital Diagnostics system with the Genius Cervical AI algorithm has received clearance from the FDA, making it the first FDA-cleared digital cytology system that combines deep-learning–based artificial intelligence with advanced volumetric imaging technology to help identify precancerous lesions and cervical cancer cells.
The system captures a digital image of a glass slide and applies an artificial intelligence algorithm to pinpoint cells that cytologists and pathologists should review. Hologic says this process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity and that there was a 28 percent reduction in false-negatives of high-grade squamous intraepithelial and more severe lesions as compared to microscopic review.
The scalable system is already commercially available in Europe, Australia, and New Zealand. It is expected to be commercially available in the U.S. early this year.