QUIBIM Precision Prostate (qp-Prostate)

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

Overview

QP-Prostate (QUIBIM Precision Prostate) is an AI-powered medical imaging software designed to revolutionize prostate MRI interpretation and enhance diagnostic accuracy for healthcare professionals. It leverages advanced artificial intelligence and image processing techniques to provide state-of-the-art analysis of prostate MRI scans. The tool is compatible with standard workstations and facilitates the visualization and analysis of DICOM data.

Key functionalities include automated segmentation of critical prostate regions, such as the peripheral zone, transitional and central zone, and seminal vesicles, with high accuracy. It also incorporates AI-QUAL™ for automated assessment of prostate MRI image quality based on PI-QUAL v2 guidelines, ensuring radiologists work with high-quality images. QP-Prostate’s AI algorithm identifies and stratifies aggressive prostate cancer lesions by likelihood, providing confidence-based classification scores. It supports PI-RADS compliant structured reporting, streamlines workflows by automating tasks, and aids in fusion biopsy and focal therapy planning. The solution is designed for seamless integration into existing PACS and electronic health record systems, delivering precise, quantitative information and automating tasks to improve and standardize decision-making in prostate cancer care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI algorithm for detection and stratification of aggressive prostate cancer lesions
  • Automated prostate segmentation (peripheral zone, transitional/central zone, seminal vesicles)
  • AI-QUALu2122 for automated prostate MRI image quality assessment (PI-QUAL v2 guidelines)
  • PI-RADS compliant structured reporting
  • Support for fusion biopsy planning
  • Support for focal therapy planning
  • Seamless integration with PACS and fusion biopsy systems
  • Automated diffusion and perfusion analysis (ADC map, synthesized b-1400s/mm2)
  • Advanced 3D visualization and editing tools
  • Risk stratification for clinically significant prostate cancer (High/Moderate risk levels)

Use Cases

  • Early detection of prostate cancer
  • Improving diagnostic accuracy for radiologists
  • Streamlining radiology workflows and reducing interpretation time
  • Assisting in fusion biopsy planning and guidance
  • Supporting focal therapy planning
  • Enhancing patient management and follow-up in prostate cancer care

What Physicians Need to Know

Key Capabilities
AI algorithm identifies and stratifies intermediate and high-grade aggressive prostate cancer lesions. Automated segmentation of the prostate (peripheral, transitional, central zones, seminal vesicles). AI-QUALu2122 for automated MRI image quality assessment based on PI-QUALv2 guidelines, including artifact detection. Automated detection of biopsy-proven, clinically significant prostate cancer lesions using biparametric input (T2W and DWI). Provides 3D output of the prostate and lesions. Offers quantitative information like prostate volume, ADC map, and perfusion metrics. Generates structured reports compliant with PI-RADS v2.1, merging AI findings with radiologist annotations. Includes editing tools and flexible overlays for AI-generated findings, ensuring clinician autonomy.
Clinical Utility
Improves diagnostic accuracy and speed for prostate cancer detection, increasing expert radiologists' detection rates by up to 90% with a 10% increase in sensitivity. Aids in fusion biopsy planning and focal therapy. Streamlines radiologists' workflows by automating tasks and ensuring PI-RADS v2.1 compliance. Minimizes unnecessary biopsies by improving scan specificity. Reduces diagnostic delays and provides a 'second opinion' to decrease intra- and inter-reader variability. Supports early detection of prostate cancer, potentially saving lives.
Integration Options
Seamless integration into PACS and fusion biopsy systems. Compatible with standard workstations for DICOM data visualization and analysis. Supports integration via AI marketplaces or distribution platforms. Offers a stand-alone web-based deployment option. Outputs are in standard DICOM formats. Strategic partnerships, such as with Ferrum Health, enable secure, scalable deployment and continuous performance monitoring within large health systems. Collaboration with Philips for integrated solutions.
Compliance Status
FDA 510(k) cleared as a CADe/CADx device for lesion detection and diagnosis capability (initially cleared in 2021 for automated segmentation). CE Mark (MDR Class IIb) for the European Union. UKCA mark for the United Kingdom. Approved by the TGA (Australia). ISO 27001:2022 certified for information security.
User Experience
Features an upgraded user interface with advanced 3D visualization and editing tools. Guarantees access to original images at all times. Provides flexible, optional, and removable AI-generated overlays, ensuring clinicians retain full autonomy and control. Designed for effortless integration into existing radiology workflows, streamlining complex processes.
Implementation Complexity
Designed for seamless integration into existing hospital systems (PACS, fusion biopsy systems). Partnerships aim for rapid implementation, with the goal of going 'live in days not months'. Compatible with standard workstations. Available as a cloud-based deployment. Automated analysis is triggered right after image acquisition, with a processing time of 1-10 minutes.
Evidence Base
Algorithms are trained on actual pathology data as ground truth. Pivotal validation included standalone and multi-reader, multi-case studies, meeting superiority endpoints of aided radiological performance versus unaided, and AUROC using biopsy as ground truth. A validated international study demonstrated 88% accuracy in prostate gland segmentation. Early clinical data indicates it can detect 10.6% more early-stage prostate cancers. Training datasets are diverse, including cases from multiple centers, magnetic fields, and vendors, with varied ethnicity and age ranges. Selected for a two-year NHS rollout across seven UK hospitals to evaluate diagnostic accuracy, cost-effectiveness, and health equity. Quibim is involved in numerous academic and industry-sponsored projects with over 27,000 prostate cancer cases in research.
Physician Tip

Leverage QP-Prostate for its AI-driven lesion detection and automated segmentation to enhance diagnostic accuracy and efficiency in prostate MRI interpretation, particularly for intermediate and high-grade aggressive cancers. Utilize the AI-QUALu2122 feature to ensure optimal image quality and reduce diagnostic variability. The structured reporting, compliant with PI-RADS v2.1, can streamline communication and standardize findings. The 3D visualization and editing tools offer greater control and aid in fusion biopsy planning. Remember that while the AI provides a robust 'second opinion' and automates many tasks, clinical judgment and oversight remain paramount.

QP-Prostate is designed for seamless integration into existing PACS and fusion biopsy systems, minimizing workflow disruption. Its compatibility with standard workstations and DICOM output ensures broad usability. Consider its cloud-based deployment and partnerships with platforms like Ferrum Health for scalable and monitored integration within larger healthcare networks. The collaboration with Philips also highlights its potential for deeper integration with MR imaging techniques.

Details

Category Oncology AI
Pricing Contact vendor
DeploymentOn-premise (standard workstation compatible) and cloud-integrated for large health systems.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

QUIBIM Precision Prostate (qp-Prostate) received its initial FDA 510(k) clearance (K203582) on February 4, 2021, as an image processing software package. A subsequent 510(k) clearance was granted on March 19, 2025, for its Computed Aided Detection and Diagnosis (CADe/CADx) capability, specifically for lesion detection and diagnosis in prostate MRI.
Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

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Press & Coverage

X-ray Interpreter
QUIBIM Precision Prostate (qp-Prostate) | FDA Radiology AI Device - X-ray Interpreter
QUIBIM Precision Prostate (qp-Prostate) is software designed to assist radiologists in viewing and analyzing prostate MRI scans, offering advanced post-processing features to quantify diffusion and perfusion characteristics. It helps clinicians visualize prostate tissue and complete structured reports without performing a direct diagnostic function.
2021-02
X-ray Interpreter
QP-Prostateu00ae CAD | FDA Radiology AI Device - X-ray Interpreter
QP-Prostateu00ae CAD is an AI-based software approved by the FDA in March 2025 that assists doctors in detecting and identifying suspicious lesions in the prostate gland using bi-parametric prostate MRI. It highlights areas of concern on images to aid physicians during interpretation and integrates with existing DICOM imaging systems and PACS.
2025-03
PMC (PubMed Central)
Theranostics and artificial intelligence: new frontiers in personalized medicine - PMC
This article reviews current and emerging AI applications in theranostics, including QUIBIM Precision Prostate (qp-Prostate) as a software to detect prostate cancer and prostate diseases. It highlights the potential of AI to revolutionize healthcare by providing personalized, data-driven insights.
2024-03
PMC (PubMed Central)
Exploiting artificial intelligence in precision oncology: an updated comprehensive review - PMC
This comprehensive review discusses the exploitation of artificial intelligence in precision oncology, listing QUIBIM Precision Prostate (qp-Prostate) as an AI-assisted tool used to enhance the detection and diagnosis of prostate cancer. It emphasizes the need for large-scale multicenter prospective studies and regulatory guidelines for safe and efficient AI use.
2025-12
Physician Ai Tools
QUIBIM Precision Prostate (qp-Prostate) vs ProstatID - Physician Ai Tools
This article provides a head-to-head comparison of QUIBIM Precision Prostate (qp-Prostate) and ProstatID, both FDA-cleared AI solutions for prostate MRI interpretation. QUIBIM Precision Prostate offers automated segmentation, AI-driven lesion detection, PI-RADS compliant reporting, and support for fusion biopsy and focal therapy planning.
unknown
FDA
K203582 - 510(k) Premarket Notification - FDA
This is the official FDA 510(k) Premarket Notification document for QUIBIM Precision Prostate (qp-Prostate), submitted by Quibim S.L. It details the regulatory information and approval for the device.
2025-12
accessdata.fda.gov
TPLC - Total Product Life Cycle - accessdata.fda.gov
This FDA document lists K203582 for QUIBIM Precision Prostate (qp-Prostate) as substantially equivalent to other devices, indicating its regulatory status.
2026-07
Constat
breastscape v1.0 (K211431) u2014 FDA 510(k) evidence - Constat
This entry mentions that K211431 shares predicate K152602 with K203582 (QUIBIM Precision Prostate (qp-Prostate)), highlighting its connection to other FDA-approved medical devices.
2026-07

Videos

Product demos, reviews, and walkthroughs for QUIBIM Precision Prostate (qp-Prostate).

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Frequently Asked Questions

qp-Prostate is designed for seamless integration with existing PACS and fusion biopsy systems, functioning as a post-processing tool for multiparametric MRI (mpMRI) data. It automates tasks like prostate volume and lesion segmentation, provides quantitative insights, and generates structured reports compliant with PI-RADS guidelines, aiming to streamline interpretation and enhance diagnostic consistency.
qp-Prostate has received FDA 510(k) clearance in the U.S. for its lesion detection and diagnosis capability, and it also holds CE Mark for the European Union, UKCA mark for the United Kingdom, and TGA approval for Australia. QUIBIM is ISO 27001:2022 certified, ensuring data security by design through encryption during storage and transfer, and compliance with HIPAA and GDPR for patient data privacy.
Alternatives include other AI-powered prostate MRI analysis platforms from various vendors, as well as traditional radiologist interpretation relying on PI-RADS scoring without AI assistance. Additionally, novel ultrasound modalities such as shear wave elastography, contrast-enhanced ultrasound, or high-frequency micro-ultrasound are emerging as potential alternatives or complementary tools to mpMRI.
While specific pricing details are not publicly disclosed, AI solutions like qp-Prostate commonly utilize subscription-based licensing models. These can be structured per-study, per-user, or based on institutional volume, with varying tiers potentially offering different features or support levels. Direct consultation with QUIBIM is typically required for detailed pricing information.
Like other AI tools, qp-Prostate's performance can be affected by factors such as image quality, patient motion, and the inherent biological heterogeneity of tumors. Challenges include small lesion size and low image contrast, and its generalizability may be impacted by variability across different MRI scanner manufacturers and acquisition protocols.
qp-Prostate's lesion detection and diagnosis capability received FDA 510(k) clearance following a pivotal validation study that met a superiority endpoint of aided radiological performance versus unaided performance. This study demonstrated improved diagnostic precision in identifying clinically significant prostate cancer and met its primary endpoint of area under the receiving operating curve (AUROC) using biopsy as ground truth.
QUIBIM offers comprehensive training for clinical staff on the proper use and interpretation of qp-Prostate results, often through online modules, webinars, or on-site sessions. Ongoing technical support, software updates, and troubleshooting assistance are typically provided by a dedicated support team to ensure continuous optimal performance.

Compare QUIBIM Precision Prostate (qp-Prostate)

VS
Quantib Prostate vs QUIBIM Precision Prostate (qp-Prostate)
Oncology AI Direct · 92/100
Both Quantib Prostate and QUIBIM Precision Prostate are FDA-cleared AI solutions designed to enhance prostate MRI interpretation through automated segmentation and PI-RADS compliant reporting. While Quantib Prostate offers…
VS
QP-Prostate® CAD vs QUIBIM Precision Prostate (qp-Prostate)
Oncology AI Direct · 95/100
These two tools, both from Quibim S.L., are highly comparable, offering FDA-cleared AI for prostate cancer detection and diagnosis using MRI with extensive overlapping features like automated segmentation,…
VS
QUIBIM Precision Prostate (qp-Prostate) vs ProstatID
Oncology AI Direct · 95/100
QUIBIM Precision Prostate and ProstatID are direct competitors, both offering FDA-cleared AI solutions for enhancing prostate MRI interpretation and aiding in cancer detection and diagnosis. While QUIBIM details…

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

Investors who backed QUIBIM Precision Prostate (qp-Prostate)

Funded through the company that built this tool.

Atria Ventures
VC AI T1
San Francisco, United States
$250k-$1M
Atria Ventures is a solo-GP firm built around a single conviction: the next decade of healthcare and life sciences will be defined…
AI/ML in Healthcare Biotech
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