QuantX

Oncology Radiology

Regulatory Status Disclosed

Overview

QuantX, originally developed by Quantitative Insights, Inc., is an FDA-cleared artificial intelligence (AI)-driven software platform designed for computer-aided diagnosis (CADx) of breast abnormalities using Magnetic Resonance Imaging (MRI) data. The system assists radiologists in the assessment and characterization of breast lesions, aiming to enhance diagnostic accuracy and efficiency. It incorporates machine learning and advanced image analysis, providing tools such as the proprietary QI Score™ and Similar Case Database Compare™ to offer comparative analysis against a robust database of abnormalities with clinically documented pathology. This helps radiologists interpret MRIs, noting differences between cancerous and non-cancerous breast lesions, and has been shown to improve diagnostic performance.

Quantitative Insights was founded in 2010 and incubated at the University of Chicago’s Polsky Center for Entrepreneurship and Innovation, based on research led by Dr. Maryellen L. Giger. The assets of QuantX were later acquired by Qlarity Imaging, a portfolio company of Paragon Biosciences, which continues to commercialize and further develop the technology.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered medical imaging analysis
  • Automated detection of anomalies
  • Quantitative assessment of imaging data
  • Integration with existing PACS systems
  • Real-time image processing
  • User-friendly interface
  • Cloud-based storage and access
  • Regulatory compliance with FDA clearance
  • Continuous software updates and improvements
  • Secure data transmission and storage
  • Scalable architecture for healthcare institutions
  • Customizable reporting tools
  • Multi-language support
  • Patient data anonymization
  • Clinical decision support tools
  • Integration with electronic health records (EHR)
  • Remote access capabilities
  • Audit trails for user activity
  • QI Scoreu2122 for malignancy likelihood
  • Similar Case Database Compareu2122

Use Cases

  • Aid radiologists in breast cancer diagnosis
  • Evaluation of breast abnormalities on MRI
  • Characterization of suspicious breast lesions
  • Improving diagnostic performance for radiologists
  • Reducing missed breast cancers
  • Multi-modality breast imaging decision support

What Physicians Need to Know

Evidence Base
QuantX is an AI-driven software that analyzes breast MRI images using machine learning and a large reference database of known cases with clinically documented pathology. It incorporates technology from two decades of research in computer-aided diagnosis from the University of Chicago's research labs.
Clinical Validation Studies
A clinical study demonstrated that QuantX improved the detection of cancerous breast tumors by 39% and increased overall diagnostic improvement by 20%. It also led to a 39% reduction in missed breast cancers without a reduction in specificity. The system received FDA clearance in 2017 based on this clinical study.
Alert Fatigue Management
While not explicitly detailed, QuantX is designed to augment radiologist interpretation by providing a single numeric value, the QuantX Scoreu2122, related to the probability of malignancy, and 'Similar Case Database Compare tools'. This approach aims to provide focused insights rather than generating numerous alerts, thereby mitigating alert fatigue.
Differential Diagnosis Support
QuantX aids in differential diagnosis by providing a 'QI Score' and 'Similar Case Database Compare tools'. It compares the analyzed abnormality to a robust database of abnormalities with known pathology, offering quantitative assessment and comparative insights to support diagnostic decisions.
Guideline Update Frequency
The platform features continuous software updates and improvements. Given its AI/machine learning foundation, updates likely involve enhancements to its models and expansion of its case database.
Clinical Workflow Integration
QuantX is designed for integration with existing PACS systems and offers features for integration with electronic health records (EHR) systems. A partnership with Blackford aims to integrate QuantX within Blackford's curated marketplace to promote workflow efficiencies, reduce deployment time, costs, and maintenance through a centralized system.
Decision Audit Trail
The system includes audit trails for user activity, ensuring traceability and accountability in its use.
Physician Tip

QuantX is a specialized AI tool for breast MRI interpretation, offering quantitative assessment (QI Score) and comparative analysis to a vast database of known cases. It's particularly useful for enhancing diagnostic accuracy and reducing missed cancers. Radiologists should leverage its integration capabilities with PACS and EHR for seamless workflow. The system also supports biopsy guidance, providing precise location and depth for interventions.

QuantX is designed for integration with existing PACS systems and offers features for EHR integration. It is also available through platforms like Blackford's curated marketplace, which can streamline deployment, maintenance, and support by providing a centralized system for accessing various imaging applications. The integration aims to enhance workflow efficiencies and expand distribution.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentSaaS
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

QuantX received FDA clearance (De Novo classification, DEN170022) on July 19, 2017 (corrected January 13, 2020) as a Class II medical device. It is a radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer, intended to aid in the characterization of breast abnormalities identified on acquired medical images such as MRI. It can also be used as an image viewer for multi-modality digital images, including ultrasound and mammography, but is not intended for primary interpretation of digital mammography images.

Integrations
EHR Not specified
Specialties Oncology, Radiology

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Videos

Product demos, reviews, and walkthroughs for QuantX.

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Frequently Asked Questions

QuantX is a software-only post-processing system designed to integrate with existing PACS systems, allowing for manual or automatic loading of images from DICOM-compatible devices. It assists radiologists by analyzing user-selected regions of interest (ROI) on breast MRI images, providing volumetric analysis and computer analytics based on morphological and enhancement characteristics to aid in diagnosis.
Clinical studies have shown that QuantX improved the detection of cancerous breast tumors by 39% and increased overall diagnostic improvement by 20%. This AI-driven tool aims to reduce missed cancers and false positives, thereby enhancing radiologists' confidence and potentially leading to faster, more accurate diagnoses and better patient outcomes.
Yes, QuantX is the first FDA-cleared AI-driven software platform specifically for breast cancer diagnosis, having received de novo regulatory clearance in July 2017. It is classified as a computer-aided diagnosis (CADx) software device and adheres to compliance standards including HIPAA, FDA 510(k), and ISO 13485.
QuantX is indicated for the evaluation of breast abnormalities in patients undergoing high-risk screening, diagnostic imaging workup, or assessment of known disease extent using MR image data. It is explicitly stated that QuantX is not intended for the primary interpretation of digital mammography images.
QuantX is distinguished as the first FDA-cleared machine-learning driven system to aid in cancer diagnosis for use in radiology, representing an advancement over earlier computer-aided detection (CAD) systems. It provides advanced AI insights and offers a 'QI Score' through comparative analysis to a robust database of abnormalities with known pathology to assist in diagnosis.
QuantX is designed with secure data transmission and storage capabilities, including features like patient data anonymization and audit trails for user activity. The platform also complies with HIPAA regulations, ensuring adherence to established standards for patient information privacy.
Specific pricing models for QuantX are not publicly detailed in the available information. However, its benefits, such as improving diagnostic performance, potentially reducing unnecessary biopsies, and enhancing overall efficiency, suggest a value proposition aimed at achieving cost savings and improving patient outcomes for healthcare institutions.

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