Avenda Health AI Prostate Cancer Planning Software

by Avenda Health  · Based in United States → — Bringing Confidence to your Prostate Cancer Treatment Decisions
Oncology Radiology Urology
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Regulatory Status Disclosed

Overview

Avenda Health’s Unfold AI (formerly iQuest) is an artificial intelligence (AI)-based decision support software designed for prostate cancer planning and management. It is indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings within the prostate oncological workflow. The software helps physicians with the segmentation of MR image features, including the prostate, and in the evaluation, quantification, and documentation of lesions. It also aids in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. Unfold AI generates a 3D Cancer Estimation Map (CEM) by combining patient-specific data from MRI scans, fusion biopsies, pathology, and PSA levels, visualizing the precise location and extent of cancer. This technology aims to provide tailored insights for prostate cancer management, leading to personalized care and enhanced treatment outcomes by improving tumor localization and supporting treatment decision-making, including active surveillance, prostatectomy, radiation therapy, and focal therapy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based decision support for prostate cancer planning
  • Generates 3D Cancer Estimation Maps (CEM) from MRI, biopsy, pathology, and PSA data
  • Precisely maps prostate cancer location and extent in 3D
  • Aids in surgical planning and treatment decision-making (active surveillance, prostatectomy, radiation, focal therapy)
  • Improves identification of tumor extent (71% improvement, over 98% sensitivity in studies)
  • Supports segmentation of MR image features and lesion documentation
  • Data exportable to compatible interventional or biopsy systems
  • Predicts extracapsular extension (ECE) risk
  • Predicts tumor volume
  • Provides encapsulation confidence score for treatment margins

Use Cases

  • Prostate cancer diagnosis and treatment planning
  • Guiding repeat biopsies for active surveillance
  • Surgical planning for prostatectomy
  • Planning for radiation therapy
  • Identifying candidates and planning for focal therapy
  • Supporting interventional, diagnostic, and treatment procedures of the prostate

What Physicians Need to Know

Evidence Base (guidelines, literature scope)
Avenda Health's Unfold AI (formerly iQuest) leverages deep-learning algorithms, integrating patient-specific data from prostate MRI, biopsies, and pathology to generate a tailored 3D cancer estimation map. The platform is built upon hundreds of thousands of patient data points collected over a decade of research and has received FDA clearance.
Clinical Validation Studies
Multiple retrospective clinical studies and peer-reviewed abstracts validate Unfold AI's features. An AI Prostate Segmentation Algorithm (AIPSA) achieved a mean dice similarity coefficient of 0.93 across 137 multi-institutional test cases, outperforming a competing product. The AI Lesion Contouring Algorithm's Cancer Estimation Map (CEM) demonstrated high efficacy in predicting clinically significant prostate cancer (csPCa) with a mean AUC of 0.92 and 85% balanced accuracy, validated on 100 prostatectomy cases. AI-assisted margins significantly outperformed manually defined margins in a multi-reader, multi-case study, achieving 84.7% balanced accuracy and reducing cancer underestimation with a 72.8% negative margin rate. Clinical trials showed that Unfold AI's guidance led physicians to change treatment recommendations in 28% of cases, often towards more localized treatments. A UCLA study indicated that Unfold AI's patient-specific encapsulation confidence score (ECS) predicted focal therapy success with a 77.7% rate.
Alert Fatigue Management
The provided information does not explicitly detail specific features for alert fatigue management. As a prostate cancer planning and decision support tool that provides 3D maps and insights, its primary function is not to generate numerous real-time alerts in the manner of an EHR for drug interactions, thus traditional 'alert fatigue' may be less applicable.
Guideline Update Frequency
The frequency of guideline updates within the software's evidence base is not explicitly stated in the available information.
Clinical Workflow Integration
Unfold AI integrates into the prostate oncological workflow by assisting with MR image segmentation, 3D cancer risk visualization, and treatment site selection. It is designed as a cloud-based web platform capable of exporting planning data in DICOM and other formats for integration with clinical systems. The software supports pre-planning for diagnostic and interventional procedures like biopsies and soft tissue ablation. It has demonstrated integrations with the PrecisionPointu00ae Transperineal Access System for biopsies and the Focal One robotic HIFU platform for high-intensity focused ultrasound procedures. The workflow involves syncing patient clinical information with Unfold AI in the cloud to generate cancer maps and lesion contours, which are then reviewed by the physician and shared with the patient.
Decision Audit Trail
Specific details about an internal 'decision audit trail' feature within the Avenda Health software are not explicitly mentioned. However, as an FDA-cleared medical device software, it is expected to adhere to regulatory requirements for audit trails, which typically track user interactions, data access, and modifications within the system for accountability and compliance.
Physician Tip

Leverage Unfold AI for a highly precise, 3D visualization of prostate cancer extent and location, which can significantly improve upon conventional imaging and biopsy methods. Utilize the personalized cancer estimation map to tailor treatment plans (including active surveillance, focal therapy, prostatectomy, and radiation therapy) with greater confidence, aiming to optimize patient outcomes and preserve quality of life. Engage patients in shared decision-making by using the clear visual representation of their cancer. Integrate the AI-generated insights to enhance the accuracy and targeting of interventional procedures like biopsies and ablations.

Avenda Health's Unfold AI is designed for seamless integration into existing clinical workflows, supporting data export in DICOM and other standard formats. Key integrations include the PrecisionPointu00ae Transperineal Access System for enhanced biopsy precision and the Focal One robotic HIFU platform for AI-assisted high-intensity focused ultrasound procedures, enabling a more tailored and precise approach to prostate cancer care.

Details

Category Clinical Decision Support & Reference, Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Price can vary from provider to provider; not yet fully covered by insurance
  • A new Category III CPT code (0898T) for reimbursement on services related to the use of Unfold AI became effective July 1, 2024, establishing a national payment rate by CMS
DeploymentCloud-based platform
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Avenda Health AI Prostate Cancer Planning Software received FDA 510(k) clearance (K221624) on November 22, 2022. It is an AI-based decision support software indicated as an adjunct to the review of MR prostate images and biopsy findings in the prostate oncological workflow, supporting segmentation, evaluation, quantification, documentation of lesions, and pre-planning for diagnostic and interventional procedures.
Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

What the Web Says

Avenda Health's Unfold AI Prostate Cancer Planning Software is an AI-driven platform designed to assist physicians in diagnosing and planning treatment for prostate cancer. It utilizes patient-specific data, including MRI scans, biopsies, and pathology reports, to create detailed 3D cancer probability maps. Studies indicate that Unfold AI significantly improves the accuracy of identifying cancer extent and predicting focal therapy success compared to traditional methods.

Overall: Positive

Strengths

  • Improved accuracy in identifying cancer extent (up to 84.7% balanced accuracy compared to 67.2% and 75.9% for conventional methods).
  • Enhanced prediction of focal therapy success (77% better than standard methods).
  • Aids in more precise treatment planning and decision-making, potentially leading to less invasive interventions.
  • Reduces underestimation of tumor size and improves negative margin rates (from 1.6% to 72.8% in studies).
  • FDA-cleared and received Breakthrough Device Designation.
  • Can improve urologists' and radiologists' abilities in identifying cancer extent by 45-fold.

Limitations

  • Limited availability, currently only in the United States through healthcare providers.
  • Relies on existing patient data (MRI, biopsy, pathology), so data quality is crucial.
  • As a new technology, long-term outcomes and widespread adoption are still being established.
  • No specific negative reviews or opinions from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found in the search results.

Based on reviews from: BioWorld, Applied Radiation Oncology, Avenda Health (Press Releases and Website), FDA, Urology Times, Quartz, Medical Technology Enterprise Consortium (MTEC), Applied Radiology, PR Newswire, The Journal of Urology, dot.LA

Last updated: 2026-07-20

Ratings & Reviews

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Press & Coverage

PR Newswire
Avenda Health's Unfold AI to be Deployed at University of Michigan Health, Expanding AI-Guided Prostate Cancer Care to the Midwest for the First Time
University of Michigan Health is the first in the Midwest to adopt Avenda Health's Unfold AI platform, an AI-powered prostate cancer mapping tool, to enhance precise treatment planning. This deployment brings advanced AI-driven 3D tumor visualization to a leading urologic oncology program.
2026-05
MedTech Innovator
Avenda Health's Unfold AI Included in Expanded Medicare Physician Fee Schedule Across West Coast and Mountain West Regions
Avenda Health's Unfold AI is now included in Medicare's Physician Fee Schedules across the West Coast and Mountain West regions, providing clearer reimbursement pathways for urologists and care teams in physician office settings. This expansion improves access to the AI prostate cancer mapping and clinical decision support platform.
2026-04
UCLA Health
AI is helping doctors see prostate cancer more clearly and guide more effective treatments
UCLA-led studies have advanced Unfold AI, an AI tool developed with Avenda Health, which combines MRI data and biopsy results to create detailed 3D prostate cancer maps. This technology aims to provide physicians with a clearer picture of tumor size and boundaries for more informed treatment decisions.
2025-12
Applied Radiology
Avenda Health's Mapping Technology, Unfold AI Enhances Prostate Cancer Staging Accuracy
Avenda Health's Unfold AI, an AI-powered cancer mapping tool, has shown to significantly outperform conventional MRI in accurately predicting prostate cancer spread, according to a pilot study presented at the American Urological Association's 2025 Annual Meeting. The study found Unfold AI achieved a 92% accuracy rate in predicting seminal vesicle invasion compared to 52% for traditional MRI.
2025-05
EDAP TMS SA
EDAP and Avenda Health Launch World's First AI-Assisted Focal Oneu00ae Robotic HIFU Procedures
EDAP TMS SA and Avenda Health announced a collaboration to offer personalized prostate cancer care, launching the world's first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures. These procedures utilize Avenda's Unfold AI technology to provide tailored, patient-specific ablation.
2024-09
PMC
Extracapsular extension risk assessment using an artificial intelligence prostate cancer mapping algorithm
A study published in PMC found that Avenda Health's Unfold AI accurately predicted extracapsular extension (ECE) risk in prostate cancer, outperforming conventional methods like MRI and nomograms. Unfold AI achieved a significantly higher area under the curve (AUC = 0.81) for patient-level ECE prediction.
2024-08
The Journal of Urology
Artificial Intelligence Improves the Ability of Physicians to Identify Prostate Cancer Extent
A study published in The Journal of Urology demonstrated that AI-assisted cancer identification with Avenda Health's Unfold AI improved urologists' and radiologists' abilities to identify cancer extent by 45 times. The study found AI-assisted cancer margins significantly outperformed cognitively-defined and hemi-gland margins.
2024-06
Imaging Technology News
Avenda Health's Revolutionary AI Mapping Tool for Prostate Cancer Achieves Landmark Category III CPT Code Designation
The American Medical Association (AMA) included a new Category III CPT code for Avenda Health's Unfold AI in its 2024 Current Procedural Terminology code set. This designation is a temporary code for new and developing technologies, solidifying Unfold AI's position in cancer care.
2023-11

Videos

Product demos, reviews, and walkthroughs for Avenda Health AI Prostate Cancer Planning Software.

View all on YouTube

Frequently Asked Questions

Avenda Health's Unfold AI is an FDA-cleared, AI-based decision support platform that uses a patient's MRI, fusion biopsy, and pathology data to generate a 3D Cancer Estimation Map. This map visualizes the precise location and extent of prostate cancer, assisting physicians in treatment selection, planning, guidance for procedures like biopsies or focal therapy, and follow-up.
Unfold AI is FDA-cleared as an AI-based decision support software for prostate cancer planning. Furthermore, it has received a Category III CPT code and a national payment rate from the Centers for Medicare & Medicaid Services (CMS), which helps establish reimbursement pathways for its use.
Unfold AI is designed to offer superior accuracy in identifying cancer location and extent compared to conventional MRI alone, which has traditionally been less precise. While competitors like Exact Imaging, Proscia, and Optellum exist in the broader AI healthcare space, Unfold AI focuses on creating a detailed 3D cancer map to improve treatment margin definition.
As a relatively new prostate cancer test, Unfold AI's full coverage by health insurance is still evolving, and prices may vary by provider. However, the establishment of a Category III CPT code (0898T) and a national payment rate from CMS effective July 1, 2024, are significant steps toward standardizing reimbursement for services related to its use.
Unfold AI is indicated for use in patients who have not yet started prostate cancer treatment and have been diagnosed with Gleason Grade 2 (GG2) or greater lesions. It functions as an adjunct decision support tool, meaning it is intended to assist physicians in their review of imaging and biopsy findings, not to replace their clinical judgment.
Unfold AI is based on extensive patient data and has been validated in multiple clinical studies, demonstrating superior accuracy in mapping prostate cancer compared to conventional methods. Recent studies have shown that AI-assisted cancer identification with Unfold AI significantly improved physicians' ability to identify cancer extent, achieving a balanced accuracy of 84.7%.

Compare Avenda Health AI Prostate Cancer Planning Software

VS
Avenda Health AI Prostate Cancer Planning Software vs Neosoma Platform
Clinical Decision Support & Reference Adjacent · 65/100
These tools are adjacent competitors, both offering AI-powered clinical decision support and radiology/imaging AI for oncology. However, Avenda Health AI specializes in prostate cancer planning, generating 3D cancer…
VS
Avenda Health AI Prostate Cancer Planning Software vs Google Cloud AI (with BAA)
Clinical Decision Support & Reference Adjacent · 65/100
Avenda Health's Unfold AI is a specialized, FDA-cleared clinical decision support tool for prostate cancer treatment planning, generating 3D cancer maps to aid physicians in surgical, radiation, and…
VS
Avenda Health AI Prostate Cancer Planning Software vs CancerLinQ SmartLinQ (RxLinQ & TriaLinQ)
Clinical Decision Support & Reference Adjacent · 60/100
Avenda Health's Unfold AI is specifically designed for prostate cancer, providing 3D cancer maps to aid in localized treatment planning and decision-making. CancerLinQ SmartLinQ, on the other hand,…
VS
Avenda Health AI Prostate Cancer Planning Software vs RAYUS Radiology (formerly Insight Health)
Clinical Decision Support & Reference Adjacent · 65/100
Avenda Health's Unfold AI is a specialized AI-powered decision support software for prostate cancer treatment planning, generating 3D cancer maps to aid physicians. RAYUS Radiology, on the other…

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17

Investors who backed Avenda Health AI Prostate Cancer Planning Software

Funded through the company that built this tool.

E12 Ventures
VC T3
Boston, United States
$250k-$1M
E12 Ventures is an early-stage venture firm with website, LinkedIn, and Crunchbase footprint, with positioning that suggests a thematic or generalist technology…
AI/ML in Healthcare Biotech
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