Vendor source
Reviewed 29 Sept 2026
Completeness Strong (72%)
The artificial intelligence-based software, Prostate Health (previously named Saige Prostate and Quantib® Prostate), provides a workflow for detection of abnormalities on MRI prostate scans.
Supported by 5 papers
General Information
Product name
Company
Modality
Main task
Not specified
Subspeciality
Disease targeted
Regulatory Information
Pathway:
MDR
Class:
Class IIb
Verified by Health AI Register
Pathway:
510(k) cleared
Class:
Class II
Verified by Health AI Register
Other certifications
Not specified
Evidence & Research
Peer-Reviewed Papers
Multicentre evaluation of artificial intelligence risk classification for detection of clinically significant prostate cancer on biparametric MRI
European Radiology · Sep 2026
Prospective effects of an artificial intelligence-based computer-aided detection system for prostate imaging on routine workflow and radiologists’ outcomes
European Journal of Radiology · Dec 2023
Bridging the experience gap in prostate multiparametric magnetic resonance imaging using artificial intelligence: A prospective multi-reader comparison study on inter-reader agreement in PI-RADS v2.1, image quality and reporting time between novice and expert readers
European Journal of Radiology · Feb 2023
Biparametric prostate MRI: impact of a deep learning-based software and of quantitative ADC values on the inter-reader agreement of experienced and inexperienced readers
La radiologia medica · Sep 2022
Quantib Prostate Compared to an Expert Radiologist for the Diagnosis of Prostate Cancer on mpMRI: A Single-Center Preliminary Study
Tomography · Aug 2022
Technical Specifications
Patient population age
Not specified
Input
Input format
Output
Output format
Integration
Deployment
Trigger for analysis
Processing time
Population
Market Presence
On market since
AI Platforms
Resellers
Not specified
Countries present
Not specified
Paying clinical customers
Not specified
Research/test users
Not specified
Pricing Information
Pricing model
Based on
Source: Vendor | First published: Dec 19, 2023 | Last updated: Sep 29, 2026