Public source

Reviewed 29 Jul 2026

Completeness Fair (39%)

Genius Cervical AI

HOLOGIC

Genius Cervical AI is a new artificial intelligence (AI) for cervical cancer screening that assists in identifying pre-cancerous lesions and cervical cancer cells, infectious organisms, and glandular component from patient samples imaged on the Genius Digital Imager.

Supported by 11 papers

Key features

Cervical cancer cells

Glandular component

Identifying pre-cancerous lesions

Infectious organisms

General Information

Product name

Genius Cervical AI

Company

Modality

Cytopathology

Main task

Detection

Subspeciality

Gynecologic cytopathology

Organ/Specimen source

Not specified

Disease targeted

Cervical cancer, Infectious diseases

Specimen type

Smear(s)

Staining

Pap

Stain subtype

Not specified

Regulatory Information

FDA Certification

Pathway:

De novo 510(k) cleared

Class:

Class II

FDA Number:

Verified by Health AI Register

CE-IVD Certification

Pathway:

In Vitro Diagnostic Directive (IVDD)

Class:

General IVD Devices

Not verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Not specified

Scanner Models Certified for Use (CE-IVD)

Not specified

Other certifications

Not specified

Evidence & Research

Peer-Reviewed Papers

Morphologic Evaluation of Hyperchromatic Crowded Groups Present in Cervical Thin Prep Cytology Tests as Identified by the Hologic Genius Digital Diagnostics System: A Descriptive Study

Diagnostic Cytopathology · Dec 2025

Technical considerations during validation of the Genius® Digital Diagnostic System

Journal of Pathology Informatics · Nov 2025

Assessment of microorganism detection in ThinPrep Papanicolaou tests utilizing the Hologic Genius Digital Diagnostics System

Am J Clin Pathol · Oct 2025

Impact of the Genius Digital Diagnostics System on workflow and accuracy compared with the ThinPrep Imaging System for review of ThinPrep Papanicolaou tests

American Journal of Clinical Pathology · Aug 2025

Papanicolaou test interpretation utilizing the Hologic Genius Digital Diagnostics System vs manual glass slide review: A retrospective study of 596 cases

American Journal of Clinical Pathology · Jul 2025

Assessment of the efficacy and accuracy of cervical cytology screening with the Hologic Genius Digital Diagnostics System

Cancer Cytopathology · Jun 2025

Assessment of reprocessed ThinPrep cytology cases after glacial acetic acid wash procedure using the Hologic Genius Digital Diagnostics System

Journal of the American Society of Cytopathology · Jun 2025

Diagnostic performance of the hologic genius digital diagnostics system for low-grade squamous intraepithelial lesion (LSIL) ThinPrep papanicolaou tests

Journal of the American Society of Cytopathology · Jan 2025

Analysis of the sensitivity of high‐grade squamous intraepithelial lesion Pap diagnosis and interobserver variability with the Hologic Genius Digital Diagnostics System

Cancer Cytopathology · Nov 2024

Validation of AI-assisted ThinPrep® Pap test screening using the GeniusTM Digital Diagnostics System

Journal of Pathology Informatics · Jul 2024

Comparison of the Hologic Genius Digital Diagnostics System with the ThinPrep Imaging System—A retrospective assessment

Cancer Cytopathology · Apr 2023

Technical Specifications

Patient population age

Not specified

Input

Not specified

Input format

Not specified

Output

Not specified

Output format

Not specified

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Population

Not specified

Viewer systems

Not specified

Market Presence

On market since

Not specified

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

Source: Public | First published: Apr 15, 2026 | Last updated: Jul 29, 2026

Genius Cervical AI - HOLOGIC