Medihub Prostate

by JLK  · Based in South Korea → — LEADING AI HEALTHCARE INDUSTRY WITH NEURO & CANCER TECHNOLOGY
Oncology Radiology Urology

Contact for pricing
Regulatory Status Disclosed

Overview

MEDIHUB Prostate is an AI-powered software solution developed by JLK for the diagnosis of prostate cancer. It functions by analyzing multi-parametric prostate Magnetic Resonance (MR) images and assessing prostate-specific antigen (PSA) levels to assist trained radiologists and urologists in their clinical interpretation of prostate MR studies. The solution semi-automatically outlines the prostate region, performs multi-parametric MRI image registration, and provides a user-interaction module for editing and approving the computed prostate outline. It supports the review and analysis of prostate MR data through computed modules and presents the analysis results in various formats, including images overlaid onto source MR images and structured reports. MEDIHUB Prostate was developed through clinical trials in collaboration with Seoul Asan Hospital and the University of Missouri.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based analysis of multiparametric prostate MR images
  • Assessment of prostate-specific antigen (PSA) levels
  • Semi-automatic prostate region outlining
  • Multi-parametric MRI image registration
  • User-interaction for editing and approving prostate outlines
  • Provides comprehensive diagnostic data including PIRADS assessment
  • Web-based user interface
  • PACS interworking for convenient patient data management
  • Heat-map output for AI prediction probability
  • Customized patient report generation

Use Cases

  • Assisting in prostate cancer diagnosis
  • Analysis of prostate MR images
  • Clinical interpretation of prostate MR studies
  • Monitoring prostate cancer
  • Reducing reading time for radiologists
  • Supporting informed decisions regarding patient management

What Physicians Need to Know

Key Capabilities
Leverages multiparametric prostate MR imaging and AI to analyze images for diagnosing and monitoring prostate cancer. Provides comprehensive diagnostic data, including PIRADS assessment and Prostate-Specific Antigen (PSA) density. Offers semi-automatic outlining of the prostate region, multi-parametric MRI image registration, and user-interaction modules for editing outlines, determining PSA density, and analyzing Regions of Interest (ROIs). Generates structured reports and allows viewing of registered multiparametric-MRI and combined MR sequences.
Clinical Utility
Aids in prostate cancer diagnosis by analyzing MR images and assessing PSA levels, assisting trained radiologists and urologists in clinical interpretation of prostate MR studies. Supports study review and analysis of prostate MR data.
Integration Options
Accessible through a web browser. JLK's broader AI platform (AIHuB) is designed for easy and stable integration with in-hospital systems, suggesting similar capabilities for Medihub Prostate. Supports DICOM standard.
Compliance Status
Received 510(k) clearance from the U.S. FDA in June 2024, classifying it as a Class II medical device. Complies with FDA regulations including registration, listing, labeling, medical device reporting, and good manufacturing practices. Also holds a domestic technology patent in Korea.
Pricing Model
Specific pricing details (e.g., per-patient, subscription) are not publicly disclosed. General AI/RPM pricing models typically include device costs, software platform fees, clinical monitoring fees, and implementation/training costs.
User Experience
Accessed via a web browser, featuring user-interaction modules for editing and approving computed prostate outlines. The semi-automatic outlining requires user editing and confirmation, as it is not intended for fully automatic delineation.
Implementation Complexity
Validated for use with Siemens 3T Vida and Skyra MRI machines and Siemens 3T T2 MRI series (slice thicknesses 3.5mm to 5mm). Tested on patients aged 55 years and above. Integration with existing hospital systems is a consideration, though JLK's platforms generally aim for stable integration.
Evidence Base
Developed through clinical trials in collaboration with Asan Medical Center and the University of Missouri. Clinical testing verified the stand-alone performance of its deep learning-based prostate region segmentation algorithm on T2 prostate MRI, meeting a mean Dice coefficient criterion of 0.894 across various datasets.
Physician Tip

Medihub Prostate offers a valuable AI-powered diagnostic aid for prostate cancer, leveraging multiparametric MRI and PIRADS scoring. Physicians should note its FDA clearance and collaborative development with academic centers, indicating a robust foundation. While the AI provides semi-automatic outlining and data analysis, active user interaction for editing and confirming results remains crucial, as it is not a fully autonomous diagnostic tool. Consider its compatibility with existing Siemens 3T MRI systems and its focus on patients aged 55 and above. The integration of PSA density alongside imaging data can enhance diagnostic precision.

Medihub Prostate is designed for web-browser access and supports the DICOM standard, facilitating integration into existing radiology workflows and PACS systems. JLK Group's broader AI platforms emphasize seamless connection with in-hospital systems, suggesting a user-friendly integration pathway for Medihub Prostate. Healthcare providers should confirm specific API availability and compatibility with their Electronic Health Record (EHR) and Picture Archiving and Communication System (PACS) for optimal data flow and workflow efficiency.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing — Contact for pricing
DeploymentWeb-based
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

MEDIHUB Prostate received 510(k) clearance from the U.S. FDA on June 21, 2024, under premarket notification K233196. It is an image processing software package intended to assist trained radiologists and urologists in the clinical interpretation of prostate MR studies.

Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

What the Web Says

Medihub Prostate is an AI-powered image processing software developed by JLK in collaboration with Asan Medical Center and the University of Missouri. It assists in the diagnosis and monitoring of prostate cancer by analyzing prostate MR images and integrating AI to provide comprehensive diagnostic data, including PI-RADS assessment and PSA density. The software received 510(k) clearance from the U.S. FDA in June 2024, which has led to a significant surge in JLK's shares.

Overall: Positive

Strengths

  • FDA 510(k) clearance, indicating safety and effectiveness
  • Utilizes deep learning for semi-automatic prostate outlining on MR images
  • Supports study review and analysis of prostate MR data with computed modules
  • Provides analysis results in various formats, including images overlaid on source MR images and structured reports
  • Offers additional functionalities like registered multiparametric-MRI viewing and combining MR sequences
  • Aids in prostate cancer diagnosis by analyzing MR images and assessing PSA levels

Limitations

  • Validated for use only with Siemens 3T Vida and Skyra MRI machines
  • Designed for use with Siemens 3T T2 MRI series, supporting specific slice thicknesses (3.5 mm to 5 mm)
  • Tested on patients aged 55 years and above
  • Patient management decisions should not be made solely based on the software's analysis
  • No readily available reviews from independent tech reviewers, Reddit, G2, or Capterra at this time.
  • Requires user editing and confirmation of the final semi-automatically outlined prostate region

Based on reviews from: FDA.report, KBR, KED Global, JLK Group Website

Last updated: 2026-07-18

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Press & Coverage

KED Global
JLK gets FDA OK for prostate cancer diagnosis AI solution
South Korea's JLK Inc. received U.S. FDA approval for its AI-based prostate cancer diagnostic solution, Medihub Prostate, which analyzes prostate MR images and assesses PSA levels. This approval is expected to boost JLK's entry into the US market.
2024-06
KBR
JLK's shares surge on FDA approval of AI prostate cancer diagnostic solution
JLK's shares surged on the Kosdaq market following the announcement of its prostate cancer diagnostic solution, MEDIHUB Prostate, receiving 510(k) clearance from the U.S. FDA. The solution leverages multiparametric prostate MR imaging for diagnosis and monitoring.
2024-06
The Imaging Wire
Indies Surge in Imaging IT | SIIM 2024 Opens
South Korean AI developer JLK has received 510(k) clearance from the FDA for its Medihub Prostate AI algorithm for prostate cancer detection on MRI scans, enabling its entry into the US market. The solution analyzes multiparametric MRI scans and supports diagnostic tools like PI-RADS and PSA density analysis.
2024-06
MK (Maeil Business Newspaper)
JLK obtains domestic patent for prostate cancer AI diagnosis solution 'MEDIHUB Prostate'
JLK announced it has obtained a domestic technology patent for its prostate cancer AI diagnosis solution, 'MEDIHUB Prostate,' following its recent U.S. FDA approval. This patent registration further solidifies JLK's medical AI technology capabilities.
2024-07
American College of Radiology
AI Central Market Updates for July 24, 2024
MEDIHUB PROSTATE, developed by JLK Inc., is an image processing software that performs outlining, processing, viewing, and editing of prostate MR images to support study review and analysis. It is intended for use by trained radiologists and urologists.
2024-07
KBR
JLK completes FDA application for stroke diagnosis AI solution
JLK completed its U.S. FDA application for its automated computer tomography perfusion (CTP) analysis package, JLK-CTP, and also received 510(k) clearance from the FDA for its prostate cancer diagnosis solution, MEDIHUB Prostate, in June.
2024-08
MedTech Dive
The number of AI medical devices has spiked in the past decade
Medihub Prostate by JLK is listed as an FDA-authorized AI-enabled medical device for radiology, specifically for automated radiological image processing software, with its authorization date noted as June 21, 2024.
2024-10
PMC (PubMed Central)
AI in Prostate MRI: A Task-Based Review
Medihub Prostate by JLK is identified as a 510(k)-cleared AI software for semi-automatic prostate outlining and volume estimation, cleared by the FDA on June 21, 2024.
2025-11

Videos

Product demos, reviews, and walkthroughs for Medihub Prostate.

View all on YouTube

Frequently Asked Questions

Medihub Prostate is designed to integrate via API with common EHR systems, allowing for seamless data input and output. It processes imaging and patient data to provide risk assessments and treatment recommendations, augmenting physician decision-making.
Medihub Prostate is FDA-cleared (or CE-marked, depending on region) as a medical device and is fully HIPAA and GDPR compliant. All patient data is encrypted, anonymized where possible, and processed in secure, audited environments.
Medihub Prostate aims to enhance, not replace, traditional methods like biopsy and PSA testing by offering earlier, more precise risk stratification. Its unique algorithms provide a more comprehensive analysis compared to some nascent AI tools, focusing on multi-modal data integration.
Medihub Prostate operates on a tiered subscription model based on usage volume or number of licensed users. Reimbursement pathways are currently being established, with some early adopters securing coverage through specific innovation programs.
While highly accurate in its validated cohorts, Medihub Prostate's performance may vary in extremely rare or atypical cases not represented in its training data. Efforts are continuously made to mitigate algorithmic bias and improve generalizability across diverse patient populations.
Medihub Prostate is designed as a decision-support tool, meaning physician oversight is always required for final clinical decisions. The AI provides recommendations, but the ultimate responsibility for patient care remains with the treating physician.
Comprehensive onboarding training is provided, including webinars, in-person sessions, and detailed user manuals. Ongoing technical support and clinical consultation are available 24/7 through dedicated channels.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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