mdprostate

mediaire

mdprostate enables AI-based static and longitudinal evaluations of prostate MRIs through automatic identification and classification of lesions according to PI-RADS 2.1. The output includes quantitative reports and visual overlays directly integrated into the PACS, with all relevant lesions marked on a sector map.

The automated graphical presentation, including the overview of prostate volume, lesion size, ADC values, and optionally PSA density, is aimed at accelerating and simplifying the evaluation.

Information source: Vendor
Last updated: November 19, 2024

General Information

General
Product name	mdprostate
Company	mediaire
Subspeciality	Abdomen
Modality	MR
Disease targeted	Prostate cancer
Key-features	Automated segmentation of the prostate with volume calculation, detection and evaluation of suspicious lesions, classification of lesions according to PI-RADS 2.1 and determination of relevant parameters (e.g., extent, EPE, index lesion), automated comparison to earlier examinations.
Suggested use	During: interactive decision support (shows abnormalities/results only on demand), report suggestion After: diagnosis verification

Technical Specifications

Data characteristics
Population	Patients suspected of (initial diagnosis), or diagnosed with (follow-up) prostate cancer.
Input	1.5T or 3T MRI systems. Sequences included in the evaluation: T2-weighted, DWI, ADC
Input format	DICOM
Output	PDF report with: Tabular overview of detected lesions and their change compared to preliminary exams, Prostate volume (optional PSA density), Slices of the most significant lesions, Schematic representation of detected lesions ≥ PI-RADS 3. Color-coded segmentation overlays
Output format	PDF, DICOM-PDF, browser-based platform, CSV-Export file
Technology
Integration	Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis	Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	2 - 3 minutes

Regulatory

Certification
CE	Certified, Class IIb , MDR
FDA	No or not yet
Intended Use Statements
Intended use (according to CE)	The product is intended for semi-automatic labeling, visualization and volumetric quantification of 3D MRI data (in DICOM format) of the prostate. The software automates the currently manual process of identifying, labeling and volumetric calculation of segmented prostate structures on 3D MRI images. The calculated volumetric data, in addition to the image data at hand, can assist trained medical professionals in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using mdprostate.

Market

Market presence
On market since	08-2023
Distribution channels	deepcOS, Sectra Amplifier Store, Angionautix, Bender, Medecon, Sanova, Supermedical, Tatramed
Countries present (clinical, non-research use)	11
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Pay-per-use
Based on	Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Assessment of a fully-automated diagnostic AI software in prostate MRI: clinical evaluation and histopathological correlation (read)
Non-peer reviewed papers on performance
Other relevant papers