Prostate Intelligence™

Lucida Medical

Prostate Intelligence software intended to assist analysis of MRI for suspected prostate cancer. It uses a combination of image processing, deep learning and machine learning methods, to segment the prostate, identify regions of interest, and calculate risk scores.

Information source: Vendor
Last updated: March 28, 2024

General Information

General
Product name	Prostate Intelligence™
Company	Lucida Medical
Subspeciality	Abdomen
Modality	MR
Disease targeted	Prostate cancer
Key-features	AI- supported prostate segmentation and volume, lesion segmentation, volumes and risk scores, PI-RADS v2.1 scoring support, structured report
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion,

Technical Specifications

Data characteristics
Population	Prostate MRI scans with suspicion of prostate cancer, males >21 years
Input	MRI, T2, DWI, DCE (optional)
Input format	DICOM
Output	Segmentation overlay, RTSTRUCT export for biopsy and 3D vizualization, structured report with key images, volumes and risk score
Output format	DICOM
Technology
Integration	Integration in standard reading environment (PACS)
Deployment	Locally on dedicated hardware, 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	1 - 10 minutes

Regulatory

Certification
CE	Certified, Class IIb , MDR
FDA	No or not yet
Intended Use Statements
Intended use (according to CE)	Device description Prostate Intelligence (the software) is designed to process MRI scans of the prostate, to support analysis for suspected prostate cancer. It uses a combination of image processing, deep learning and machine learning methods, to segment the prostate, identify regions of interest, and calculate risk scores. These outputs may be considered by the radiologist to determine whether to recommend a biopsy. The software further provides a report template. The report template refers to the full set of medical images as per standard of care. The software does not alter the original medical images and does not provide a direct diagnosis. Intended use Software to assist analysis of MRI for suspected prostate cancer. Indications for use Prostate IntelligenceTM is a radiological analysis software indicated for use in the assessment of MRI images of males aged 21 or over with the suspicion of prostate cancer.

Market

Market presence
On market since	05-2021
Distribution channels	Eureka Clinical AI, Ferrum Health, OpenRad
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Pay-per-use, Subscription
Based on	Number of analyses, Number of installations

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers	Abstract: Multi-stage AI analysis system to support prostate cancer diagnostic imaging (read) Abstract: P9: AI for prostate MRI: results from a large multicentre, multi-vendor external validation study (read)