QP-Prostate® CAD

by Quibim S.L.  · Based in Spain → — Your AI solution for advanced prostate cancer detection.
Oncology Radiology Urology

Contact for pricing
Regulatory Status Disclosed

Overview

QP-Prostate® CAD by Quibim S.L. is an FDA-cleared artificial intelligence-based Computer-Aided Detection and Diagnosis (CADe/CADx) image processing software designed to support radiologists in the detection and diagnosis of clinically significant prostate cancer (csPCa) from bi-parametric prostate MRI scans. The solution leverages AI algorithms, trained with pathology data, to automatically detect and identify suspected lesions within the prostate gland. It provides quantitative information, including prostate volume and dimensions, Apparent Diffusion Coefficient (ADC) maps, and perfusion metrics, compiling this data into a PI-RADS 2.1 structured report template.

QP-Prostate® CAD aims to enhance diagnostic precision, accelerate image processing, and improve radiologists’ accuracy in identifying aggressive prostate cancer. It streamlines workflows by automating tasks such as prostate segmentation and offers advanced viewing with 3D visualization. The software integrates seamlessly into standard reading environments like PACS and fusion biopsy systems, delivering actionable insights to oncology teams and supporting fusion biopsy planning and focal therapy. Additionally, it includes AI-QUAL™ for automated prostate MRI image quality assessment, ensuring radiologists work with high-quality images.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automatic lesion detection and risk scoring (High and Moderate) for clinically significant prostate cancer (csPCa)
  • Quantitative information: prostate volume and dimensions, Apparent Diffusion Coefficient (ADC) map, computed high b-value and perfusion metrics (K trans, K ep, V e)
  • PI-RADS 2.1 structured report template
  • Prostate segmentation (peripheral zone, transitional and central zone, seminal vesicles)
  • AI-QUALu2122 for automated prostate MRI image quality assessment based on PI-QUAL v2 guidelines
  • Seamless integration into PACS and fusion biopsy systems
  • Advanced viewing with 3D visualization
  • Algorithms trained on actual pathology/biopsy data
  • Supports fusion biopsy planning and focal therapy
  • Cloud-based deployment

Use Cases

  • Aid in interpreting prostate MRI studies for prostate cancer detection
  • Improve diagnostic accuracy for clinically significant prostate cancer
  • Streamline radiology workflows and automate tasks like prostate volume and lesion segmentation
  • Risk stratification and early diagnosis of aggressive prostate cancer
  • Support fusion biopsy planning and focal therapy
  • Enhance clinical communication with structured reports

What Physicians Need to Know

Key Capabilities
QP-Prostate® CAD is an AI-powered medical imaging software that assists radiologists in detecting clinically significant prostate cancer. It offers automated prostate segmentation with 88% accuracy, lesion detection, and risk scoring (High and Moderate) for the presence of clinically significant prostate cancer. The tool also provides quantitative information such as prostate volume and dimensions, Apparent Diffusion Coefficient (ADC) map, computed high b-value, and perfusion metrics (K trans, K ep, V e). It streamlines workflows by automating tasks like prostate volume and lesion segmentation and ensures compliance with PI-RADS v2.1 guidelines. Additionally, it includes AI-QUAL™ for automated assessment of prostate MRI image quality based on PI-QUAL v2 guidelines, offering automated quality scoring, standardized reporting, and artifact detection. The software provides a 3D output of the prostate gland and lesions, and supports fusion biopsy planning and focal therapy.
Clinical Utility
QP-Prostate® CAD aims to enhance diagnostic accuracy and early detection of prostate cancer, particularly aggressive forms. It helps radiologists deliver quicker and more accurate assessments, potentially increasing radiologist sensitivity by up to 10% and achieving prostate cancer detection rates approaching 90%. The tool minimizes the need for unnecessary biopsies by improving scan specificity and aids in risk stratification and timely treatment. It also helps address the challenges faced by radiology departments due to the growing demand for prostate MRI scans, improving consistency in interpretation and adherence to PI-RADS guidelines.
Integration Options
QP-Prostate® CAD is designed for seamless integration into existing systems, including PACS and fusion biopsy systems. It can be integrated into a standard reading environment, via an AI marketplace or distribution platform, or as a standalone web-based solution. The QP-Link® securely integrates with PACS and imaging equipment for automated study analysis. Quibim has also partnered with Philips to offer an integrated solution for MR prostate exams.
Compliance Status
QP-Prostate® CAD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for lesion detection and diagnosis capabilities, making it a CADe/CADx device. It also holds CE mark (Class IIb) for the European Union, a UKCA mark for the United Kingdom, and is approved by the TGA (Australia). The product was initially cleared by the FDA in 2021 for automated segmentation of prostate regions.
Pricing Model
The pricing model for QP-Prostate® is subscription-based, determined by the number of analyses.
User Experience
The software offers an upgraded user interface with flexible overlays for AI-generated findings, allowing clinicians full autonomy and control. It supports advanced viewing with 3D visualization and provides a structured report template based on PI-RADS guidelines to enhance clinical communication. The workflow is fully automated, aiming to streamline the diagnostic process.
Implementation Complexity
The solution is cloud-based and can be deployed with automated analysis triggered right after image acquisition, with a processing time of 1-10 minutes. It integrates seamlessly into existing systems, including PACS.
Evidence Base
QP-Prostate® CAD's algorithms are trained with pathology data as ground truth. Clinical validation studies, including a multi-reader, multi-case study, have demonstrated its superior performance. A pilot study conducted in 2023 at Massachusetts General Hospital showed that QP-Prostate increased radiologist sensitivity by up to 10%. The software's segmentation accuracy is clinically validated at 88%.
Physician Tip

QP-Prostate® CAD can significantly enhance prostate MRI interpretation by automating segmentation and lesion detection, providing quantitative data, and ensuring PI-RADS compliance. This can lead to more accurate and timely diagnoses, potentially reducing unnecessary biopsies. The AI-QUAL™ feature helps ensure high-quality images for diagnosis. Remember that while the AI provides valuable insights, the radiologist retains full control and should review and adjust findings as needed. The integration with PACS and fusion biopsy systems aims to streamline your workflow, making it a natural extension of your existing practice.

QP-Prostate® CAD offers flexible integration options, including direct integration with PACS and fusion biopsy systems, as well as deployment via AI marketplaces or as a standalone web-based solution. The QP-Link® facilitates secure integration with imaging equipment. Quibim's partnership with Philips also highlights its capability for integrated solutions within existing radiology platforms.

Details

Category Oncology AI
Pricing Contact for pricing
DeploymentCloud-based, with integration into standard reading environments (PACS) and AI marketplaces.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

What the Web Says

QP-Prostate® CAD is an AI-powered software designed to enhance the accuracy, efficiency, and consistency of prostate MRI examinations for detecting and diagnosing prostate cancer. It automates post-processing tasks, provides precise measurements, and expedites segmentation and reporting, integrating with existing PACS and DICOM workstations. The solution has received FDA 510(k) clearance, CE marking, UKCA marking, and TGA approval, indicating its compliance with international regulatory standards.

Overall: Positive

Strengths

  • Increases radiologist sensitivity and detection rates for clinically significant prostate cancer.
  • Automates image processing, segmentation of prostate regions, and lesion detection, streamlining workflows.
  • Reduces variability in radiologists' interpretations, promoting more consistent diagnoses.
  • Provides risk stratification for identified lesions and supports early diagnosis and treatment decisions.
  • Trained and validated using actual pathology data as ground truth, contributing to its accuracy.
  • Offers features like AI-QUAL for automated MRI image quality assessment based on PI-QUAL v2 guidelines.

Limitations

  • One study indicated high sensitivity but low specificity, meaning it may flag non-cancerous lesions as suspicious, potentially limiting biopsy reduction.
  • The same study noted spectrum bias, as it only included men with PI-RADS ≥3, not a general MRI population.
  • The tool does not replace the radiologist's decision or the doctor's consultation.
  • No direct head-to-head comparison with expert radiologist readings in some studies, making it difficult to ascertain added value over human interpretation alone.

Based on reviews from: radmagazine.com, ijfmr.com, medpath.com, businesswire.com, auntminnie.com, quibim.ai, fluteproject.eu, nih.gov, philips.com, convenzis.co.uk, drdominguezesteban.com, healthairegister.com, reddit.com, mayoclinic.org

Last updated: 2026-10-31

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Press & Coverage

quibim.ai
QP-Prostate® Receives Health Canada Licence, Expanding Quibim's Reach to Canada
Quibim's QP-Prostate® has received a Medical Device Licence from Health Canada, allowing its AI-powered prostate MRI analysis tool to be used in Canada. This expands Quibim's global reach, as QP-Prostate® is already cleared in numerous other countries including the EU, US, UK, and Australia.
2026-06
quibim.ai
Quibim's AI Tool for Prostate Cancer Detection Selected for NHS Rollout Across Seven UK Hospitals
Quibim's QP-Prostate has been chosen for a major NHS-backed rollout across seven hospitals in England to improve early detection of prostate cancer. This two-year project will assess the tool's impact on diagnostic accuracy, cost-effectiveness, and health equity, aiming to detect more early-stage prostate cancers.
2025-07
quibim.ai
Quibim's QP-Prostate® CAD, including lesion detection and diagnosis capability, cleared by FDA
Quibim announced that its QP-Prostate® CAD solution, specifically its prostate cancer lesion detection capability, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance allows Quibim to enter the U.S. market with its AI-powered technology, which has already been implemented in Europe, the UK, and Australia.
2025-03
quibim.ai
Quibim to Launch Next-Generation Oncology Ecosystem Platform at RSNA 2025
Quibim will launch its next-generation oncology ecosystem platform at RSNA 2025, positioning QP-Prostate® as a comprehensive, end-to-end management workflow for prostate cancer care. This update aims to support clinicians from image acquisition through diagnosis, patient management, and follow-up.
2025-11
quibim.ai
Quibim Adds Industry-Leading Cancer Detection Capability to QP-Prostate®
Quibim has added an industry-leading cancer detection capability to its AI-based prostate tool, QP-Prostate, which uses algorithms trained on actual pathology data. The updated product has received CE and UKCA marks, clearing it for use by clinicians in the European Union and the United Kingdom.
2024-01
quibim.ai
Quibim scores CE mark and UKCA certification for QP-Prostate®
Quibim has obtained MDR (class IIb) and UKCA certifications for QP-Prostate®, making it one of the first AI products approved under the new MDR regulation. This allows the company to commercialize QP-Prostate® in the European and British markets.
2022-10

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Frequently Asked Questions

QP-Prostate® CAD is an AI-powered medical imaging software designed to support radiologists in detecting clinically significant prostate cancer (csPCa) by automating tasks like prostate segmentation, lesion detection, and risk scoring. It provides quantitative information such as prostate volume, dimensions, and perfusion metrics, and generates a structured report based on PI-RADS guidelines. However, QP-Prostate® does not provide a definitive diagnosis; its outputs require review by qualified physicians. It may also have limitations such as not detecting lesions in the seminal vesicles and a cap on the number of lesions detected per case.
QP-Prostate® CAD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for prostate cancer lesion detection and diagnosis. It also holds a CE mark for the European Union, a UKCA mark for the United Kingdom, and is approved by the TGA in Australia, making it cleared for use by clinicians in these markets.
While QP-Prostate® CAD is a specialized AI tool for prostate MRI analysis, other AI solutions exist in the oncology AI space for prostate cancer, such as Paige Prostate and ArteraAI Prostate. For general healthcare analytics software, alternatives like QGenda Advanced Scheduling for Providers, Waystar, and Personify Health are noted, though these serve different primary functions than AI-powered image analysis. Additionally, traditional multiparametric MRI (mpMRI) remains the benchmark for prostate cancer diagnosis, with biparametric MRI (bpMRI) being a cost-effective alternative.
QP-Prostate® CAD is offered under a subscription-based pricing model. The cost is typically determined by the number of analyses performed.
QP-Prostate® CAD aims to accelerate image processing, improve radiologists' accuracy in detecting cancer, and provide actionable insights to oncology teams. It streamlines workflows by automating tasks like prostate segmentation and lesion detection, and ensures compliance with PI-RADS v2.1 guidelines. This can lead to more consistent clinically significant prostate cancer detection and improved patient outcomes.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-19 | First Added: 2026-04-19

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