Avenda Health AI Prostate Cancer Planning Software

by Avenda Health  · Based in United States → — See With Clarity. Act With Certainty. A revolutionary platform that delivers tailored insights for prostate cancer management, paving the way for personalized care and enhanced treatment outcomes.
Oncology Radiology Urology

Varies by provider
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
Avenda Health's Unfold AI platform combines imaging (MRI), pathology, biomarkers, and clinical data to create personalized 3D cancer maps. [13, 19] It leverages deep learning algorithms and has been developed using hundreds of thousands of patient data points over 10 years of research. [6, 20] The software was previously known as iQuest. [8]
Clinical Validation Studies
Unfold AI has undergone multiple clinical validation studies. [6] A multi-reader, multi-case study published in The Journal of Urology in 2024, involving seven urologists and three radiologists from five institutions, demonstrated that AI-assisted cancer margins significantly outperformed cognitively-defined and hemi-gland margins with a balanced accuracy of 84.7% compared to 67.2% and 75.9%, respectively. [3, 10, 11] This study also showed that AI-assisted margins reduced the underestimation of cancer extent, with a negative margin rate of 72.8% compared to 1.6% for cognitively-defined margins. [10, 11] Another retrospective study indicated that the AI software outperformed conventional contouring methods and accurately assessed the likelihood of residual clinically significant prostate cancer. [3, 11] The software has been shown to improve tumor margin creation over conventional treatment planning from 56% to 80%. [17] Unfold AI's cancer estimation maps were strongly correlated to true tumor volume with R2 = 0.81, outperforming conventional metrics. [5] The AI algorithm for automatic segmentation of the prostate based on MRI images was validated on 137 multi-institutional test cases, showing a mean dice similarity coefficient of 0.93. [8] The cancer estimation map (CEM) was validated on 100 multi-institutional prostatectomy cases, proving highly effective at predicting clinically significant prostate cancer (csPCa) with a mean AUC of 0.92 and balanced accuracy of 85%. [8]
Alert Fatigue Management
Not specifically addressed in the provided information.
Override Rate Data
In clinical settings, 28% of urologists altered their treatment recommendations based on Unfold AI's analysis, often shifting towards less invasive options. [20]
Differential Diagnosis Support
The software provides a cancer estimation map (CEM) that visualizes where the cancer is in 3D, significantly outperforming MRI's ability to identify all cancer in the prostate. [6] It assigns a probability to each voxel within the prostate for containing clinically significant prostate cancer (csPCa). [9] This detailed mapping aids in understanding the extent of the disease. [9]
Guideline Update Frequency
Not specifically addressed in the provided information.
Clinical Workflow Integration
Unfold AI is designed to support the prostate oncological workflow by assisting with segmentation of MR image features, evaluation, quantification, documentation of lesions, and pre-planning for diagnostic and interventional procedures like biopsy and soft tissue ablation. [9] It can be used for active surveillance, surgical interventions (whole or partial prostatectomy, robotic surgery), focal therapy (HIFU ablation, cryotherapy), and radiotherapy. [13, 19] The platform has recently launched "Surgery Mode" to integrate directly into the operating room, providing real-time 3D cancer mapping and risk feedback during procedures. [12, 14] The information can be exported into compatible interventional or biopsy systems. [9] Unfold AI is also integrated with the PrecisionPoint® Transperineal Access System for safer and more precise biopsies. [15]
Decision Audit Trail
Not specifically addressed in the provided information.
Physician Tip

Unfold AI provides a comprehensive 3D map of prostate cancer, integrating MRI, biopsy, pathology, and PSA data, which can significantly enhance treatment planning and decision-making across various stages of care, from active surveillance to surgery and radiation. [6, 13, 19] The platform's ability to accurately delineate cancer margins and predict tumor volume can lead to more precise treatments, potentially reducing side effects and recurrence rates. [5, 10, 11] Consider utilizing the new 'Surgery Mode' for real-time intraoperative guidance during prostate cancer surgeries, especially for nerve-sparing decisions. [12, 14] The tool has been shown to alter treatment recommendations in a significant percentage of cases, often towards less invasive options, which can improve patient quality of life. [20]

Unfold AI integrates patient-specific data from MRI, fusion biopsy, pathology, and PSA. [6] It can export planning information to compatible interventional and biopsy systems. [9] The platform has demonstrated integration with the PrecisionPoint® Transperineal Access System for enhanced biopsy procedures. [15] Additionally, Unfold AI has collaborated with EDAP TMS SA to offer AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures. [18]

Details

Category Clinical Decision Support & Reference, Oncology AI, Radiology & Imaging AI
Pricing Varies by provider
DeploymentCloud-based
API AvailableUnknown
Data ExportUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Yes AI-estimated
SOC 2 Yes AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

Support & Reliability

Training ProvidedUnknown

What the Web Says

Avenda Health's AI Prostate Cancer Planning Software, iQuest, is designed to assist urologists in planning prostate cancer treatments. It utilizes AI to analyze patient data, including MRI scans, to create 3D models of the prostate and identify tumor locations, aiming for more precise and personalized treatment approaches.

Overall: Positive

Strengths

  • Aids in precise tumor localization using AI and MRI data.
  • Generates 3D models for better visualization of the prostate and tumors.
  • Supports personalized treatment planning for prostate cancer.
  • Potential to improve treatment efficacy by targeting cancerous tissue more accurately.
  • May help in preserving healthy tissue during treatment.
  • Designed to integrate into existing clinical workflows.

Limitations

  • Relatively new technology, long-term outcomes still being established.
  • Requires high-quality MRI data for optimal performance.
  • Dependence on AI algorithms, which may have limitations or biases.
  • Integration into diverse healthcare IT systems might present challenges.
  • Requires training for medical professionals to effectively utilize the software.
  • Specific user reviews from independent platforms like G2 or Capterra are not readily available.

Based on reviews from: Avenda Health Website, Medical Technology News Articles

Last updated: 2026-10-29

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Press & Coverage

FDA
Avenda Health AI Prostate Cancer Planning Software
The Avenda Health AI Prostate Cancer Planning Software is an AI-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. It received 510(k) clearance on November 22, 2022.
2022-11
HealthOpSolutions
Arizona Urology's AI Rollout Shows Why Clinical Technology Is a Workforce Project
Arizona Urology has adopted Avenda Health's Unfold AI platform for prostate cancer mapping across its practices, utilizing it for robotic prostatectomy planning, surgical guidance, and identifying candidates for focal therapy. The article discusses the operational implications of integrating AI in a multi-site specialty practice.
2026-09
OncologyAI Registry
Avenda Health AI Prostate Cancer Planning Software
The Avenda Health AI Prostate Cancer Planning Software is an AI-based decision-support adjunct to MRI + biopsy review for the prostate oncological workflow, with lesion characterization functions intended for use on patients with pathology-confirmed Gleason Grade Group (GGG) ≥ 2 lesions. It is 510(k) cleared.
2026-05
Journal of Translational Medicine (via NIH.gov)
Artificial intelligence in precision oncology: current applications and future perspectives
Avenda Health AI Prostate Cancer Planning Software, also known as "Unfold AI," is an AI-based software that integrates patient data and deep learning algorithms to enhance the accuracy of diagnosis and treatment planning for prostate cancer.
2025-12
Orthogonal
List of FDA-Cleared SaMD
Avenda Health AI Prostate Cancer Planning Software received FDA 510(k) clearance on November 22, 2022, and is listed under Radiology in this compilation of FDA-cleared Software as a Medical Devices (SaMD).
2024-10
NIH.gov
Artificial intelligence in prostate MRI: a task-based review
Avenda Health AI Prostate Cancer Planning Software is listed as a Class II, 510(k)-cleared device, approved on November 22, 2022, for prostate and lesion segmentation, and biopsy/ablation tool placement simulation.
2025-11

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-powered software that creates personalized 3D maps of prostate cancer. It combines patient data from MRI scans, fusion biopsies, pathology, and PSA levels to visualize the cancer's location, size, and extent. This detailed mapping helps physicians in treatment selection, planning, and guidance for various options like active surveillance, focal therapy, surgery, and radiotherapy, ultimately aiming to improve outcomes and preserve quality of life.
Unfold AI supports clinical decision-making across the entire prostate cancer care continuum. For active surveillance, it can guide repeat biopsies. For surgical interventions, it enhances planning for procedures like prostatectomy and robotic surgery, aiding in nerve-sparing decisions. In focal therapy, it helps determine the precise area to treat, and for radiotherapy, it assists in defining accurate radiation margins.
Unfold AI is intended for patients diagnosed with Gleason Grade 2 (GG2) or greater prostate cancer who have not yet started treatment. It requires specific patient data including MRI, fusion biopsy, pathology, and PSA results. The software is indicated as an adjunct to the review of MR prostate images and biopsy findings, meaning it is a decision support tool and not a standalone diagnostic.
Traditional MRI scans often miss a significant portion of prostate tumor volume, with studies showing about 68% of a tumor's volume can be undetectable. Unfold AI, by combining multiple data points and using AI algorithms, has demonstrated superior accuracy in identifying cancer extent. It has a 97% sensitivity rate in detecting cancer size and location, and studies have shown it improved urologists' and radiologists' abilities to determine cancer extent by 71%.
Yes, Avenda Health's Unfold AI (formerly known as iQuest) received FDA 510(k) clearance in December 2022. It is classified as 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.
The price for an Unfold AI analysis can vary by provider, and it is not yet fully covered by all insurance plans. However, Avenda Health is working to standardize prices and some portions of the test may be covered by insurance if the patient has prostate cancer. Medicare reimbursement for Unfold AI in physician office settings has expanded across the West Coast and Mountain West regions, with physicians receiving Medicare reimbursement since 2025.
While the information does not explicitly list direct alternatives, it highlights that Unfold AI overcomes limitations of traditional methods like visual MRI interpretation alone. The software is designed to improve upon conventional contouring methods and current clinical workflows for prostate cancer planning.

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

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