FDA Clears AI-Powered Digital Cytology Platform for Cervical Cancer

The Food and Drug Administration (FDA) has granted 510(k) clearance to the Genius Digital Diagnostics System, an artificial intelligence (AI)-enabled digital cytology platform that may facilitate enhanced sensitivity for early diagnosis of cervical cancer.

While traditional cervical cancer screenings have involved microscopic review of samples from Pap smear testing, the Genius Digital Diagnostics System facilitates digital image review of these samples with a Genius Cervical AI algorithm that alerts clinicians to suspicious cells for further review, according to Hologic, the developer of the Genius Digital Diagnostics System.

In comparison to microscopic review of Pap smear testing, Hologic noted that research has demonstrated a 28 percent reduction in false negatives for high-grade squamous intraepithelial lesions and other severe lesions with the Genius Digital Diagnostics System.

“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 Jennifer Schneiders, Ph.D., the president of diagnostic solutions at Hologic.