QP-Prostate® CAD
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
QP-Prostateu00ae CAD offers significant advantages by enhancing diagnostic confidence and efficiency in prostate MRI interpretation. Leverage its AI-driven lesion detection and quantitative insights for more precise identification of clinically significant prostate cancer. The automated segmentation and structured reporting can streamline your workflow, allowing more time for complex case review. Its compatibility with fusion biopsy systems also aids in precise planning. Remember that this tool is intended as a concurrent read to aid interpretation, not to replace physician judgment. Utilize the AI-QUAL feature to ensure you are working with high-quality MRI scans from the outset.
QP-Prostateu00ae CAD is built for seamless integration into existing radiology infrastructure, particularly PACS and fusion biopsy systems, minimizing workflow disruption. Its DICOM output ensures compatibility with various workstations. The availability through AI marketplaces and strategic partnerships with imaging companies like Philips further expands its accessibility and potential for integrated solutions within a broader healthcare ecosystem.
Details
| Category | Oncology AI |
| Pricing | Contact for pricing |
| Deployment | Cloud-based, with integration into standard reading environments (PACS) and AI marketplaces. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated QP-Prostate® CAD received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on March 18, 2025, as a Computer Aided Detection and Diagnosis (CADe/CADx) image processing software for the detection and identification of suspected lesions in the prostate gland based on bi-parametric prostate MRI. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Radiology, Urology |
What the Web Says
QP-Prostateu00ae CAD is an AI-powered software designed to assist physicians in detecting and diagnosing prostate cancer from bi-parametric prostate MRI scans. It has received FDA 510(k) clearance in the U.S. and holds CE and UKCA marks, as well as TGA approval in Australia, indicating its clearance for clinical use in these regions. The software aims to improve diagnostic accuracy, streamline radiologists' workflows, and potentially reduce the need for unnecessary biopsies.
Overall: PositiveStrengths
- Increases radiologists' detection rates by up to 90% with a 10% increase in sensitivity.
- Automates segmentation of critical prostate regions, such as the transition zone, peripheral zone, and seminal vesicles, and identifies suspicious lesions.
- Streamlines workflows by automating post-processing tasks, providing precise measurements, and expediting segmentation and reporting.
- Offers standardized reporting following PI-RADS guidelines and includes a configurable structured report prepopulated with analysis results.
- Integrates seamlessly with existing DICOM imaging systems and PACS.
- Minimizes the need for unnecessary biopsies by improving scan specificity.
Limitations
- Patient management decisions should not be based solely on the results of QP-Prostateu00ae CAD.
- The 1.5T MRI subgroup showed a minor deviation in performance compared to 3T acquisitions, suggesting 3T acquisitions are preferable when available.
- While AI can standardize detection, variability in radiologists' interpretations remains a challenge that AI aims to address.
Based on reviews from: accessdata.fda.gov, Quibim Website, X-ray Interpreter, AuntMinnie, Business Wire, Flute Project, RAD Magazine - The voice of medical imaging and clinical oncology, PMC - NIH
Last updated: 2026-07-19
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