DeepBio DeepDx® Prostate

by DeepBio  · Based in South Korea → — AI-Powered Precision in Prostate Cancer Grading

Overview

DeepDx® Prostate is a clinically validated and CE-marked AI diagnostic support software for prostate cancer. The software analyzes digitized slide images of Hematoxylin & Eosin (H&E) stained prostate specimens to detect and localize areas of interest. These areas of interest are detected based on their severity in accordance with the Gleason Scoring System. DeepDx® Prostate generates consistency as a diagnostics support software. It is designed to alleviate the shortage of pathologists and their heavy workload, while reducing diagnostic subjectivity and variability.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based diagnostics support including ROI detection, Gleason scores, grade group, and quantification of important matrix
  • Fast and accurate analysis (30 seconds per core) with 99% sensitivity and 97% specificity
  • Clinically validated and CE-marked
  • Approved by Korea MFDS and CE marked
  • Versatile deployment: Cloud & On-Premise
  • Colored overlays for Gleason patterns 3, 4, and 5
  • Tumor & pattern quantification (proportions of each Gleason pattern, tumor-to-tissue ratios)
  • Real-time modification of quantitative metrics as annotations are made
  • Annotation tools for modifying AI analysis results and automatic measurements of total tissue and tumor lengths
  • Detection of adverse histological features: Cribriform Pattern 4, Intraductal Carcinoma (IDC-P), Perineural Invasion (PNI), and High-Grade Prostatic Intraepithelial Neoplasia (HGPIN)

Use Cases

  • Automated detection and localization of prostate cancer lesions in H&E stained prostate specimens
  • Automated histological grading based on the Gleason system and ISUP Grade Groups
  • Quantification of tumor involvement and key metrics for prognosis
  • Assisting pathologists in tumor severity determination and confirmation of diagnoses
  • Reducing diagnostic subjectivity and variability among pathologists
  • Streamlining research workflows and standardizing data in prostate cancer research

Details

Category N/A
Pricing Unknown — unknown
DeploymentCloud & On-Premise
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Unknown

DeepDx® Prostate has received FDA clearance for AI-assisted prostate cancer grading. DeepDx-Prostate Pro also received a Class 3 in-vitro diagnostic medical device approval from the Ministry of Food and Drug Safety (Korean FDA), marking it as the first AI-based medical device globally to assist in classifying prostate cancer severity.

Integrations
EHR Not specified
Specialties All specialties

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Suggest an Edit → | Last Verified: 2026-10-16 | First Added: 2026-10-16
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