ProstatID

by ScanMed  · Based in United States → — North America's first and only FDA-Cleared AI software for the Screening, Detection and Diagnosis of Prostate Cancer.
Oncology Radiology Urology

Not publicly available
Regulatory Status Disclosed

Overview

ProstatID is an advanced artificial intelligence (AI) software tool designed to assist radiologists and other physicians in the screening, detection, and diagnosis of prostate cancer using MRI scans. While the FDA clearance (K212783) was granted to ScanMed, LLC, the product is actively developed and marketed by Bot Image, Inc., with Dr. Randall Jones being a key figure associated with both entities.

The software processes MRI images (T2W, DWI, and ADC data) using cloud-based computing and AI image interpretation to provide highly accurate prostate cancer diagnostics. It offers a colorized translucent overlay on 2D axial T2 MRI to identify suspicious soft tissue lesions and utilizes the PI-RADS system to score the probability of cancer. ProstatID generates 3D prostate tumor models and provides lesion risk scores, assisting physicians in treatment planning and cognitive targeting for interventionalists.

Key benefits include significantly improved radiologist performance, enhanced detection accuracy, and a reduction in false positives, leading to more confident diagnoses and potentially fewer unwarranted biopsies. The system is MRI system agnostic, compatible with various GE, Siemens, and Philips 1.5T and 3T MRI systems. It operates as a Software as a Service (SaaS) solution, integrating seamlessly with existing PACS systems via a secure, HIPAA-compliant connection, delivering real-time diagnostic outputs typically within minutes.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Use Cases

  • Prostate cancer screening programs
  • Assisting in prostate cancer detection and diagnosis from MRI
  • Enhancing radiologist performance and confidence in MRI interpretation
  • Guiding treatment planning and cognitive targeting for interventionalists
  • Improving departmental workflow and efficiency in radiology
  • Supporting active surveillance protocols for prostate cancer

What Physicians Need to Know

Key Capabilities
ProstatID is an AI-powered software for the screening, detection, and diagnosis of prostate cancer, analyzing non-contrast prostate MRI scans. It provides colorized translucent overlays of suspicious lesions, assigns cancer probability/risk scores, and suggests PI-RADS scores. The tool generates 3D volumes of the prostate and suspect cancerous tissue for enhanced visualization and treatment planning. It also measures organ and lesion volumes and has been shown to reduce radiologist read time.
Clinical Utility
This tool facilitates early and accurate detection of prostate cancer, significantly improving diagnostic accuracy and reducing false positives. It helps reduce unnecessary biopsies by decreasing false-positive interpretations. ProstatID enhances physician confidence and accuracy in diagnosis and aids in treatment planning and targeting for interventionalists and oncologists. It supports active surveillance and enables low-cost prostate cancer screening using rapid non-contrast MRI. The software also reduces inter-reader variability among radiologists.
Integration Options
ProstatID operates as a Software-as-a-Service (SaaS) model, utilizing cloud-based computing. It seamlessly integrates into existing PACS workflows by automatically appending its output to the patient study. A secure VPN connection is required between the radiology department server/MRI system and the cloud-hosted ProstatID server. The software is MRI system agnostic, compatible with major manufacturers like GE, Siemens, and Philips (1.5T and 3.0T systems), and uses DICOM protocol for inputs and outputs. It can also be integrated with fusion biopsy guidance systems.
Compliance Status
ProstatID is FDA 510(k) cleared, initially in July 2022 for diagnosis and detection, with expanded clearance in March 2023 for prostate cancer screening. It is HIPAA compliant and cyber-secure. The software has also achieved CE Mark certification under EU MDR (October 2025) and UKCA certification (November 2025).
Pricing Model
ProstatID is offered as a Software-as-a-Service (SaaS) with a low, predictable per-study fee, requiring no upfront hardware investment. The per-case cost can be covered by additional billing associated with the use of Computer-Aided Detection (CAD). Its 3D prostate tumor modeling output is reimbursable by Medicare and United Healthcare using CPT code 76377.
User Experience
The software is designed for a 'zero-click' workflow for technologists and offers hands-free operation. It provides near real-time diagnostic outputs, typically within 5 minutes, which are appended directly to the patient study and viewable on existing PACS/viewing stations without additional effort or equipment. ProstatID aims to improve physician confidence and provides clear visual understanding through colorized overlays and 3D views, which can aid in patient communication.
Support Quality
Bot Image's IT team collaborates with facility IT for seamless PACS connection. Physician testimonials highlight positive experiences and reliance on the tool for accurate diagnoses. Additional resources and supporting studies are available on the Bot Image website.
Implementation Complexity
Implementation is described as simple and fast, with secure PACS integration achievable in approximately one hour. The software requires no additional hardware or viewers and connects via a secure VPN tunnel.
Evidence Base
Two clinical studies involving 25 abdominal radiologists demonstrated significant improvement in reader performance, accuracy, and reduced false positives with ProstatID. A standalone study reported a 93.6% AUROC for ProstatID, outperforming the highest human reader's score of 75.9%. The AI was trained on thousands of MRI scans, radiological interpretations, biopsies, and pathology results. Studies show a proven reduction of unnecessary biopsies by over 30% and an improvement in PCa detection greater than 6.6% over leading radiologists. It has also demonstrated a reduction in radiologist read time from 20-30 minutes to around 5 minutes per case. Multiple case studies illustrate its real-world impact, including finding missed cancers and avoiding unnecessary biopsies. FDA validation studies confirmed its system-agnostic performance across various MRI manufacturers and field strengths. Peer-reviewed articles have also been published.
Physician Tip

ProstatID acts as an 'expert at your side,' significantly enhancing diagnostic confidence and reducing inter-reader variability in prostate MRI interpretation. Leverage its rapid, non-contrast MRI analysis to streamline workflow, reduce read times, and potentially decrease unnecessary biopsies. The 3D lesion mapping and risk scoring are invaluable for precise treatment planning and effective active surveillance. Utilize the clear visual outputs to improve patient communication and shared decision-making.

ProstatID offers seamless integration into existing radiology workflows via a secure, cloud-based SaaS model. Its MRI system agnosticism ensures compatibility with diverse hardware from major vendors (GE, Siemens, Philips). The DICOM-compliant output is automatically appended to patient studies, eliminating the need for new viewers or hardware. Furthermore, its ability to integrate with fusion biopsy guidance systems provides a comprehensive solution from diagnosis to intervention.

Details

Category Oncology AI
Pricing Not publicly available — Per-click cost; percentage of sales.
DeploymentSaaS (Software as a Service), cloud-based, secure VPN connection, PACS to PACS integration.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

ProstatID (K212783) received FDA 510(k) clearance on July 8, 2022. It is classified as a radiological computer-assisted detection (CADe) and diagnostic (CADx) software-only device intended to assist trained radiologists in the detection, assessment, and characterization of lesions suspicious for cancer using MR image data.

Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

What the Web Says

ProstatID is an FDA-cleared AI software designed to assist physicians in the screening, detection, and diagnosis of prostate cancer using MRI. It aims to improve diagnostic accuracy, reduce interpretation time for radiologists, and decrease unnecessary biopsies. Physicians have expressed positive opinions, noting its efficiency and ability to provide a visual understanding that enhances communication with patients and guides treatment decisions.

Overall: Positive

Strengths

  • Significantly improves radiologic interpretation accuracy, with a standalone AUROC of 93.6% compared to human readers at 75.9%.
  • Reduces false positives by over 30% and improves prostate cancer detection by more than 6.6%.
  • Decreases radiologists' read time from 20-30 minutes to approximately 5 minutes per case.
  • Identifies clinically significant cancers that were initially missed by human readers.
  • Provides a visual understanding that enhances communication with patients and guides treatment decisions.
  • Seamlessly integrates into existing PACS workflows with a zero-click operation.

Limitations

  • One user reported a technical issue where their MRI study failed to process due to acquisition parameters falling outside recommended ranges.
  • No specific negative reviews or opinions from healthcare IT, tech reviewers, G2, or Capterra were found in the search results.
  • Reddit discussions about prostatitis generally focus on personal experiences and treatments for the condition itself, not specifically on diagnostic software like ProstatID.

Based on reviews from: Bot Imageu2122 AI, AuntMinnie, Mayo Clinic Connect, Xtalks, pharmaphorum, Reddit, TrustRadius, G2

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

PR Newswire
Bot Image, Inc. Earns CE Mark Certification for ProstatIDu00ae AI Prostate MRI Software Under EU MDR
Bot Image, Inc. announced that its ProstatIDu00ae software received CE certification under the European Union's Medical Device Regulation (EU) 2017/745, opening the European market for the FDA-cleared AI platform for prostate MRI interpretation.
2025-10
Urology Times
CPT code verified for 3D prostate tumor modeling software
A Current Procedural Terminology (CPT) code (76377) has been verified for ProstatID, an AI software for 3D prostate tumor modeling, to facilitate reimbursement for its use with Medicare and United Healthcare.
2024-07
AuntMinnie
Bot Image highlights performance of ProstatID in study
Bot Image highlighted the performance of its FDA-cleared ProstatID AI software in a study evaluating its ability to detect, diagnose, and screen for prostate cancer, achieving an AUC of 0.936 compared to radiologists' 0.742.
2024-01
PR Newswire
Revolutionizing Prostate Cancer Care with Bot Image's ProstatIDu2122 and bpMRI
Bot Image's ProstatID, in conjunction with Bi-parametric MRI (bpMRI), offers a non-invasive, radiation-free imaging solution for early and accurate prostate cancer detection, diagnosis, and management.
2023-09
AuntMinnie
Bot Image's prostate MRI AI software wins new clearance
Bot Image secured an expanded FDA clearance for its ProstatID AI software, allowing its use in prostate cancer screening on MRI and biparametric MRI, in addition to its initial clearance for detection and diagnosis.
2023-03
Xtalks
AI-Driven Software ProstatID by Bot Image Receives FDA Clearance for Diagnosis and Detection of Prostate Cancer
Bot Image announced that its ProstatID software received clearance from the US FDA for detecting and diagnosing prostate cancer by combining AI with traditional MRI scanning.
2022-08
Applied Radiology
FDA Clears AI Software for MRI-Based Prostate Diagnosis
Bot Image announced that the FDA cleared its AI-driven medical device CAD software, ProstatID, designed to improve the accuracy and speed of prostate cancer detection and diagnosis using MRI.
2022-08
Diagnostic Imaging
FDA Clears New AI Software for MRI Detection of Prostate Cancer
An emerging AI software program, ProstatID (Bot Image), received 510(k) clearance from the FDA to enhance the efficiency and accuracy of prostate cancer diagnosis with MRI.
2022-08

Videos

Product demos, reviews, and walkthroughs for ProstatID.

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Frequently Asked Questions

ProstatID is a cloud-based Software-as-a-Service (SaaS) solution designed to integrate seamlessly with existing PACS and RIS systems via a secure VPN connection. After a technologist performs standard MRI sequences, the study is pushed to Bot Image's PACS, and ProstatID processes the data, returning an appended series with AI-generated results and a report, typically within five minutes. This allows physicians to efficiently review insights such as lesion detection, PI-RADS scoring, and 3D views alongside the original MRI data.
ProstatID is North America's first and only FDA-Cleared AI software specifically for the screening, detection, and diagnosis of prostate cancer. It operates as a secure, HIPAA-compliant SaaS device, requiring a secure VPN connection for all data transfer between the radiology department's server or MRI system and the cloud-based ProstatID server, ensuring robust data privacy and cybersecurity.
ProstatID is uniquely FDA-cleared for the detection, diagnosis, and monitoring of prostate cancer using both standard and non-invasive bi-parametric MRI, often eliminating the need for a contrast agent. Clinical studies have demonstrated that ProstatID significantly improves radiologist interpretation accuracy, achieving a standalone AUROC of 93.6% compared to human readers, and it effectively reduces false positives while increasing early cancer detections.
ProstatID is offered as a cloud-based SaaS platform, which means there is no upfront hardware investment, and it typically involves a low, predictable per-study fee. Its implementation can lead to significant cost savings by reducing unnecessary biopsies, improving workflow efficiency, and decreasing radiologist read time, thereby enhancing overall productivity and asset utilization.
While ProstatID is system-agnostic and compatible with various MRI vendors and field strengths (1.5T and 3T), it specifically analyzes T2W, DWI, and ADC MRI data, and it does not incorporate DCE images in its analysis. Although it significantly enhances diagnostic accuracy, AI tools like ProstatID are intended as adjunctive aids, and clinical judgment remains paramount, particularly in complex cases or when dealing with variable image quality.
ProstatID's efficacy is substantiated by two clinical studies involving 25 radiologists, which demonstrated a significant improvement in interpretation accuracy, achieving a standalone AUROC of 93.6% for detecting and diagnosing prostate cancer. This enhanced accuracy facilitates earlier and more precise diagnoses, reduces the incidence of unnecessary biopsies, and boosts physician confidence, ultimately contributing to improved patient outcomes.

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