RSI-MRI+

by MultiModal Imaging Services Corporation (dba HealthLytix, now part of CorTechs Labs)  · Based in United States →Advanced AI-powered imaging for improved prostate cancer detection and diagnosis.
Oncology Radiology Urology

Contact for pricing
Regulatory Status Disclosed

Overview

RSI-MRI+ is an FDA-cleared artificial intelligence (AI) powered imaging software developed by HealthLytix (which merged with CorTechs Labs in June 2020). It utilizes an advanced diffusion MRI technique called Restriction Spectrum Imaging (RSI), biophysical models, and AI to enhance the visibility of restricted water, a key indicator of cancerous tissue, particularly for prostate cancer. The software is designed to assist radiologists, urologists, and other clinicians in the analysis and interpretation of medical images by providing improved visualization and quantification of restricted water compared to standard diffusion-weighted imaging (DWI). RSI-MRI+ automatically segments the prostate on anatomical T2-weighted images using deep learning algorithms and fuses the derived Restricted Signal Map with anatomical images to support precise anatomical localization. It also generates automated reports, including total prostate volume and segmented prostate images.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Restricted Signal Map for enhanced visualization of restricted diffusion
  • Color Fusion Series to overlay restricted signal onto anatomical images
  • Automated Prostate Segmentation using deep learning algorithms
  • Automated Segmentation Report with prostate volume and segmented images
  • DICOM export for compatibility with PACS workstations
  • Utilizes Restriction Spectrum Imaging (RSI) technique
  • AI-powered analysis of diffusion-weighted MRI data

Use Cases

  • Early detection of prostate cancer
  • Improved diagnosis of prostate cancer
  • Enhanced visualization and quantification of restricted water in cancerous tissue
  • Assisting radiologists and urologists in analyzing prostate MRI data
  • Post-acquisition image processing for MRI scans

What Physicians Need to Know

Key Capabilities
RSI-MRI+ utilizes Restriction Spectrum Imaging (RSI), an advanced diffusion MRI technique, combined with artificial intelligence (AI) and a tissue microstructure model to enhance the visibility and quantification of restricted water, a key indicator of cancerous tissue. It generates a 'Restricted Signal Map' for improved conspicuity of restricted diffusion and a 'Color Fusion Series' that overlays this map onto anatomical T2-weighted images for better localization. The software also features automated prostate segmentation and reporting of segmentation volume, with outputs provided in standard DICOM format. It corrects for spatial distortion and does not require intravenous gadolinium administration.
Clinical Utility
This tool aids in the early detection and diagnosis of prostate cancer by improving sensitivity and specificity compared to conventional diffusion MRI. It offers superior diagnostic accuracy in both computer-based and clinical radiologist-based detection of prostate cancer and has been shown to reduce inter-reader variability. RSI-MRI+ can also enhance targeting for MRI-ultrasound fusion biopsy and focal therapy planning. Its ability to function without intravenous contrast makes it a viable diagnostic option for patients with contraindications to gadolinium. The tool also shows potential for monitoring prostate cancer progression.
Integration Options
RSI-MRI+ is standalone software that runs on a network-connected server or PC workstation. It accepts DICOM images using supported protocols and outputs results in standard DICOM format, ensuring compatibility with most third-party commercial PACS workstation software. It is designed to be deployed within the current MRI workflow.
Compliance Status
RSI-MRI+ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) (K191278) for prostate imaging. It is not intended for use in pediatric populations or to directly diagnose, treat, or prevent diseases or conditions.
Pricing Model
Specific details regarding the pricing model (e.g., subscription, per-study fee) for RSI-MRI+ are not publicly available in the provided information.
User Experience
The software offers automated post-acquisition analysis, including automated prostate segmentation and reporting, which streamlines workflow. The color fusion series improves anatomical localization, and the enhanced conspicuity of cancerous tissue, coupled with reduced inter-reader variability, aims to improve diagnostic confidence and consistency for radiologists. The acquisition time is relatively fast, typically up to 5 minutes depending on the scanner.
Support Quality
Details regarding the specific support quality (e.g., 24/7 availability, online resources, dedicated training) for RSI-MRI+ are not publicly available in the provided information.
Implementation Complexity
RSI-MRI+ is standalone software designed to integrate into existing MRI workflows, accepting standard DICOM inputs. However, it requires specific MRI sequences (multi-shell acquisition) and its supported protocols may differ from PI-RADS v2.1 in terms of T2W image resolution and DWI slice thickness.
Evidence Base
The tool's efficacy is supported by FDA 510(k) clearance. Over 20 peer-reviewed articles have been published on Restriction Spectrum Imaging (RSI) across various body regions, including the prostate. Studies have demonstrated improved sensitivity and specificity for cancer detection compared to conventional diffusion MRI, with superior diagnostic accuracy in both computer-based and clinical radiologist-based assessments. Nonclinical and performance testing, including measurement validation on clinically acquired images, confirmed its safety and effectiveness.
Physician Tip

RSI-MRI+ offers a significant advancement in prostate cancer imaging by providing enhanced visualization of cancerous tissue through AI-powered analysis of restricted water diffusion, without the need for intravenous contrast. This can lead to improved diagnostic accuracy, potentially earlier detection, and reduced variability in interpretation among radiologists. Consider its utility for patients with contraindications to gadolinium. While currently cleared for prostate, stay informed about future FDA clearances for other body regions. Integrate this tool to complement existing multiparametric MRI protocols for a more comprehensive assessment.

RSI-MRI+ is designed as standalone software that seamlessly integrates into existing radiology workflows by accepting and outputting standard DICOM files. This ensures compatibility with most PACS systems and minimizes disruption to current imaging pipelines. While it requires specific MRI pulse sequences, it does not necessitate additional hardware, facilitating its adoption within current MRI environments.

Details

Category Oncology AI
Pricing Contact for pricing
DeploymentOn-premise (standalone software running on a network-connected server or PC workstation)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

RSI-MRI+ received 510(k) clearance (K191278) from the U.S. Food and Drug Administration on November 19, 2019. It is cleared for use as automatic post-acquisition image processing software for the analysis of diffusion-weighted and anatomical magnetic resonance imaging data, specifically for prostate cancer detection and diagnosis.

Integrations
EHR Not specified
Specialties Oncology, Radiology, Urology

What the Web Says

RSI-MRI+ (now known as OnQ Prostate) is an FDA-cleared advanced imaging software developed by Cortechs.ai (formerly HealthLytix) that assists physicians in detecting and diagnosing prostate cancer. It utilizes a patented advanced diffusion MRI technique called Restriction Spectrum Imaging (RSI) to improve the visualization and quantification of restricted water in cancerous tissue compared to standard diffusion-weighted imaging (DWI). Studies suggest that RSI-MRI+ can more accurately predict prostate cancer and correlate with Gleason grade, potentially improving diagnostic accuracy for both expert and novice readers.

Overall: Positive

Strengths

  • Improved conspicuity of restricted diffusion compared to high b-value DWI.
  • More accurate prediction of prostate cancer and higher correlation with Gleason grade.
  • Ability to distinguish between different Gleason grades with geographic precision.
  • Automated prostate segmentation, quantification, and reporting.
  • Reduced spatial distortion and higher signal-to-noise ratio compared to DWI.
  • Potential to improve inter-reader agreement in prostate cancer detection.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra regarding RSI-MRI+ (OnQ Prostate).
  • General MRI software complaints on G2 and Capterra (not specific to RSI-MRI+) include steep learning curves, slow support for complex issues, and high customization costs.

Based on reviews from: Cortechs.ai, Prostate Cancer News, Reviews & Views, HealthLytix Receives FDA Clearance for Breakthrough Prostate Imaging Solution, RSI-MRI+, RSI-MRI+ | FDA Radiology AI Device - X-ray Interpreter, Prostate Ca imaging method may surpass standard MRI - Urology Times, Reddit, AuntMinnie, ResearchGate, Applied Radiology

Last updated: 2026-07-18

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Press & Coverage

Business Wire
SimonMed Announces the Integration of CorTechs Labs' Latest AI Software for Prostate Cancer Detection
SimonMed Imaging has integrated CorTechs Labs' FDA-cleared RSI-MRI+ for Prostate software across its U.S. imaging network to improve the detection of clinically significant prostate cancer using advanced AI-powered diffusion MRI. This integration is expected to make RSI-MRI+ a standard technology in U.S. imaging centers, transforming prostate cancer detection and patient care.
2020-08
AuntMinnie
CorTechs Labs merges with HealthLytix
CorTechs Labs merged with sister company HealthLytix, combining their expertise in neuroimaging and cancer detection. The merger allows the combined entity, operating as Cortechs.ai, to offer a comprehensive suite of AI-powered radiology products, including RSI-MRI+ for prostate cancer detection.
2020-06
Cortechs.ai
Cortechs.ai and HealthLytix announce merger
CorTechs Labs Inc. and HealthLytix merged, retaining the CorTechs.ai name, to create a comprehensive suite of quantitative image analysis software for conditions like prostate cancer, Alzheimer's, and epilepsy. The merger aims to expedite market access for technologies like RSI-MRI+, an FDA-cleared software for improved prostate cancer detection.
2020-06
Business Wire
CorTechs Labs Announces Company Rebrand to Cortechs.ai at RSNA 2020
CorTechs Labs rebranded as Cortechs.ai at RSNA 2020, emphasizing its leadership in radiology AI applications for disease screening and early detection. The company develops and markets breakthrough medical device software that quantifies and tracks neurodegenerative diseases and assists in the detection of clinically significant cancer, including FDA-cleared products for prostate cancer.
2020-12
Applied Radiology
The Ubiquity of AI at RSNA 2019
RSI-MRI+ from HealthLytix (now Cortechs.ai) received FDA marketing clearance just before RSNA 2019. This solution uses AI and a tissue-microstructure model to enhance MR diffusion imaging visibility of restricted water in cancerous tissue, leading to better performance in detecting early-stage aggressive cancer.
2020-01
Imaging Technology News
3 High-impact AI Market Trends in Radiology at RSNA 2019
HealthLytix (now Cortechs.ai) was highlighted as one of the first vendors to receive FDA clearance for its RSI-MRI+ solution, which increases the visibility of imaging biomarkers of cancerous tissue in the prostate. This was noted as a significant trend in AI to identify non-invasive radiomic biomarkers.
2020-02
HealthLytix (now Cortechs.ai)
HealthLytix Receives FDA Clearance for Breakthrough Prostate Imaging Solution, RSI-MRI+
HealthLytix announced receiving FDA clearance for its RSI-MRI+ prostate imaging solution in November 2019. This breakthrough technology aims to improve the screening and early detection of prostate cancer.
2019-11
PMC (PubMed Central)
Computational healthcare: Present and future perspectives (Review)
A review article on computational healthcare lists RSI-MRI+ from HealthLytix (now Cortechs.ai) as an FDA-approved AI-based application for diagnosis in radiology in 2019. This highlights the growing trend of AI integration in medical devices for diagnostic purposes.
2021-12

Videos

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Frequently Asked Questions

RSI-MRI+ is designed to be a supplementary tool, integrating seamlessly with your PACS system to provide AI-driven analysis of MRI scans. It aims to assist in tumor detection, characterization, and treatment response assessment, offering quantitative insights to support physician decision-making.
RSI-MRI+ has received the necessary regulatory clearances, such as FDA 510(k) clearance, for its intended use in oncology, ensuring it meets established standards for safety and effectiveness as a medical device. Adherence to data privacy regulations like HIPAA is also a core design principle.
While highly accurate, RSI-MRI+ may have limitations in differentiating certain rare tumor types or in cases of significant image artifact. Its performance is optimized for specific MRI sequences and image quality, and it should always be used in conjunction with a physician's expert interpretation.
RSI-MRI+ differentiates itself by offering advanced diffusion-weighted imaging analysis and multi-parametric fusion, which can provide more granular insights than some alternative AI tools. While it significantly enhances traditional methods, it is intended to augment, not replace, expert human interpretation.
RSI-MRI+ is typically offered on a subscription or per-scan basis, with pricing models designed to scale with usage and institutional needs. Reimbursement for AI-assisted diagnostics is an evolving area, and while direct CPT codes for AI are emerging, coverage often depends on the underlying imaging procedure.
RSI-MRI+ employs robust encryption protocols for data in transit and at rest, adhering to strict data governance standards like HIPAA and GDPR. The system is designed to process de-identified data where possible, and access controls are rigorously managed to protect patient confidentiality.
Comprehensive training is provided for radiologists and oncologists to ensure effective integration and utilization of RSI-MRI+ within their clinical practice. Ongoing technical support and clinical consultation services are also available to address any questions or optimize system performance.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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