Saige-Dx

by DeepHealth  · Based in United States → — Empowering breakthroughs in care through imaging.
Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

DeepHealth’s Saige-Dx is an advanced AI-powered mammography diagnostic software designed to assist radiologists in the more effective detection of breast cancer. Built on sophisticated deep-learning algorithms, Saige-Dx automatically identifies suspicious lesions in mammograms and assigns a suspicion level to both individual findings and the entire case. This technology aims to enhance diagnostic accuracy, enable earlier cancer detection, and reduce unnecessary patient recalls. It analyzes both digital breast tomosynthesis (DBT) and 2D mammograms, providing critical insights to interpreting physicians. Saige-Dx is a core component of RadNet’s Enhanced Breast Cancer Detection (EBCD) service, demonstrating improved radiologist performance in multi-reader studies. The software is designed to integrate into existing radiology workflows, offering capabilities like case prioritization for high-suspicion exams.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered detection of suspicious lesions in mammograms
  • Assigns a suspicion level to each finding and the entire case
  • Helps detect and diagnose breast cancer earlier
  • Reduces unnecessary recalls
  • Improves radiologist performance (increased cancer detection, lower false positive rate)
  • Analyzes digital breast tomosynthesis (DBT) and 2D mammograms
  • Outputs bounding boxes circumscribing detected findings
  • Provides case-level and finding-level outputs
  • Compatible with various DBT hardware
  • Can be used for triage (prioritizing suspicious cases)

Use Cases

  • Breast cancer screening and early detection
  • Assisting radiologists in mammography interpretation
  • Improving diagnostic accuracy and efficiency in breast imaging
  • Reducing false positives and unnecessary recalls in mammography
  • Prioritizing high-suspicion mammograms for faster review
  • Integration into Enhanced Breast Cancer Detection (EBCD) services

What Physicians Need to Know

Key Capabilities
Saige-Dx is an AI-powered software designed to assist radiologists in detecting breast cancer by analyzing digital breast tomosynthesis (DBT) and 2D mammograms. It identifies suspicious lesions, assigns suspicion levels to individual findings and the entire case, and can process prior screening exams to reduce false positive alerts. The software outputs bounding boxes around detected findings and assigns a Finding Suspicion Level, indicating the degree of suspicion that a finding is malignant. It also generates a Case Suspicion Level for the entire mammogram. Saige-Dx is a key component of RadNet's Enhanced Breast Cancer Detection (EBCD) service.
Clinical Utility
Saige-Dx is intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware. It aims to improve diagnostic accuracy and efficiency in breast cancer detection. Studies have shown that using Saige-Dx can improve radiologist performance in interpreting DBT screening examinations, with an average improvement in AUC of 0.06 at the case level and 0.11 at the lesion level. It has been associated with a 21.6% increase in breast cancer detection in a multi-stage AI-driven workflow. The software can help detect subtle lesions that are difficult to find, potentially leading to earlier cancer detection and reduced unnecessary recalls. It also helps reduce false positive marks per image by dropping false positive bounding boxes when a matching prior finding is identified.
Integration Options
Saige-Dx is designed to fit in parallel with the standard-of-care workflow. It encapsulates results into a DICOM Structured Report (SR) object, which can be overlaid on original mammogram images using a standard viewing workstation. It also creates a DICOM Secondary Capture (SC) object with a summary report of the results. The software is compatible with various mammography systems, including GE HealthCare's Senographe Pristina™ and Siemens systems.
Compliance Status
Saige-Dx is an FDA-cleared Class II medical device (product code QDQ). It has received multiple FDA 510(k) clearances, including for analyzing DBT mammograms and for prior exam integration. DeepHealth has demonstrated that differences in newer versions do not alter the safety or effectiveness of the device. The company adheres to standards such as ISO 14971 (risk management) and IEC 62304 (medical device software life cycles). It also complies with HIPAA, HITECH, ISO 13485, FDA 21 CFR Part 820, and FDA 21 CFR Part 11.
Pricing Model
The software fees for Saige-Dx are not publicly available. However, RadNet charges patients an extra fee for AI mammography under its Enhanced Breast Cancer Detection (EBCD) service. The pricing model is subscription-based.
User Experience
User reviews indicate that Saige-Dx has significantly improved diagnostic accuracy and workflow efficiency. Users have found the integration with existing systems seamless and the AI capabilities impressive. The user interface is described as intuitive, facilitating easy adoption by staff. The support team at DeepHealth has been noted as responsive and helpful.
Support Quality
The support team at DeepHealth is described as responsive and helpful throughout the implementation process. The company also provides continuous updates and improvements to the Saige-Dx platform.
Implementation Complexity
The integration with existing systems has been described as seamless. Saige-Dx is designed to fit in parallel with the standard-of-care workflow, outputting results in DICOM Structured Report and Secondary Capture formats for seamless integration into clinical workflows.
Evidence Base
Saige-Dx has been validated through multiple studies. A reader study published in Radiology: AI, involving 18 readers and 240 cases, showed an increase in AUC from 0.87 to 0.93 with AI assistance. Another study found that all 18 radiologists showed improved performance when using Saige-Dx. The software's performance was evaluated in two retrospective, standalone studies involving 2,425 and 684 cases, demonstrating non-inferiority in AUC. A multicenter ASSURE study showed a 21.6% increase in breast cancer detection with a multi-stage AI-driven workflow combining Saige-Dx with an AI-supported safeguard review. The algorithms were trained on over a million images, 100,000 cases, and 8,000 biopsy-proven cancers from diverse populations.
Physician Tip

Saige-Dx is an adjunct tool and should not replace a physician's own review of a mammogram; decisions should not be made solely based on its analysis. While it can improve reader performance and potentially reduce reading time, the exact amount of time saved in real-world use has not been prospectively studied. The ability to process prior exams can help reduce false positives, which is a significant issue in radiology. Consider its use as a concurrent reading aid to augment your interpretation and potentially detect subtle lesions earlier.

Saige-Dx integrates into existing clinical workflows by generating DICOM Structured Reports and Secondary Capture objects that can be overlaid on original mammogram images using standard viewing workstations. It is compatible with various mammography systems, including those from GE HealthCare and Siemens.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-native, on-premise, or hybrid
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Saige-Dx by DeepHealth is an FDA-cleared AI-powered software designed to assist radiologists in detecting breast cancer by analyzing mammograms, including both digital breast tomosynthesis (DBT) and 2D images. It identifies suspicious lesions, assigns suspicion levels for findings and cases, and is intended to be used as a concurrent reading aid for interpreting physicians. The software has been validated through multiple studies, demonstrating improved performance in detecting breast cancer and is integrated into RadNet's Enhanced Breast Cancer Detection (EBCD) service.

Overall: Positive

Strengths

  • Improved diagnostic accuracy and efficiency for radiologists in detecting breast cancer.
  • Reduces false alarms and helps in finding early cancers.
  • Enhances decision-making processes with AI-driven insights.
  • Seamless integration with existing systems and intuitive user interface.
  • Trained on a vast dataset, including over a million images and thousands of biopsy-proven cancers, from diverse populations.
  • Can lower recall rates while increasing cancer detection rates.

Limitations

  • It is an adjunct tool and not intended to replace a physician's own review of a mammogram; decisions should not be made solely based on AI analysis.
  • Independent proof of benefit is considered thin, as the main reader study was conducted by the vendor's own employees.
  • The case set for studies was retrospective and enriched, meaning it measures reader assistance on a curated sample rather than real-world screening outcomes.
  • Some services utilizing Saige-Dx, like RadNet's EBCD program, may incur an additional fee for patients.
  • While increasing cancer detection, a multi-stage AI-driven workflow with Saige-Dx also led to a 5.7% increased recall rate.
  • The portfolio is still being merged, and groups desiring independent proof or a single product rather than a roadmap might need to wait.

Based on reviews from: fda.gov, myebcdmammo.com, appliedradiology.com, computerreview.com, diagnosticimaging.com, healthaidb.com, medaiverdict.com, vercel.app, auntminnie.com, nih.gov, fiercebiotech.com, radnet.com, stocktitan.net, researchgate.net

Last updated: 2026-10-29

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Saige-Dx

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

vercel.app
DeepHealth's Saige-Dx Receives FDA 510(k) Clearance for Digital Breast Tomosynthesis (DBT) Mammograms with Prior Exam Compatibility
DeepHealth's Saige-Dx has received FDA 510(k) clearance to analyze digital breast tomosynthesis (DBT) mammograms, expanding its capabilities to include processing prior exams to reduce false positive alerts and adding compatibility with Siemens systems.
2026-10
fda.gov
FDA 510(k) Premarket Notification for Saige-Dx
The FDA has issued a 510(k) Premarket Notification for Saige-Dx, a software device from DeepHealth, Inc. that processes screening mammograms using artificial intelligence to aid interpreting radiologists.
2026-10
oncologyairegistry.org
Saige-Dx™ DeepHealth, Inc. United States Mammography
Saige-Dx by DeepHealth, Inc. is listed as a 510(k) cleared mammography tool in the United States, indicating its regulatory status.
2026-05
fda.gov
FDA 510(k) Summary - Saige-Dx - DeepHealth, Inc.
Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists, analyzing digital breast tomosynthesis (DBT) mammograms to identify soft tissue lesions and calcifications.
2026-06
deephealth.com
DeepHealth Expands Its AI-Powered Mammography Software with Expanded FDA 510(k) Clearance
DeepHealth received expanded FDA 510(k) clearance for its mammography software, SmartMammo Dx (also known as Saige-Dx), making it compatible with GE HealthCare's Senographe Pristina™ mammography systems.
2024-11
myebcdmammo.com
RadNet Launches the Enhanced Breast Cancer Detection Program, Providing Women in New York and New Jersey a New State-of-the-Art Solution Powered by Artificial Intelligence
RadNet has launched its Enhanced Breast Cancer Detection (EBCD) service, which includes Saige-Dx, an FDA-cleared AI technology powered by DeepHealth, to provide improved accuracy in breast cancer detection.
2024-05
thno.org
Theranostics and artificial intelligence: new frontiers in personalized medicine
Saige-Dx by DeepHealth, Inc. is listed as radiological software for lesions suspicious for cancer, with FDA clearance K220105 in 2022, in a review article discussing AI applications in theranostics.
2024-03
appliedradiology.com
Radiology Imaging Associates Launches AI-Powered Enhanced Breast Cancer Detection Program
Radiology Imaging Associates, a division of RadNet, Inc., has implemented its new Enhanced Breast Cancer Detection (EBCD) service, which incorporates Saige-Dx, an FDA-cleared AI technology powered by DeepHealth.
2023-02

Videos

Product demos, reviews, and walkthroughs for Saige-Dx.

View all on YouTube

Frequently Asked Questions

Saige-Dx is an AI-powered software designed to help radiologists interpret mammograms by automatically identifying suspicious lesions and assigning suspicion levels to findings and entire cases. It processes both digital breast tomosynthesis (DBT) and 2D mammography images to enhance diagnostic accuracy and efficiency. The software is intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms.
Saige-Dx is FDA-cleared as a Class II medical device and has CE Marking. It also complies with various standards including ISO 13485, ISO 14971, IEC 62304, IEC 62366, and several IEC 60601 series.
Yes, Saige-Dx is strictly labeled as an adjunct tool and is not intended to replace a physician's own review of a mammogram. Decisions should not be made solely based on its analysis. The FDA clearance is based on retrospective, standalone data, and users should monitor its impact on their clinical workflow and diagnostic accuracy in real-life settings.
While Saige-Dx is a prominent AI tool for mammography interpretation, other companies also offer AI solutions for breast cancer detection. For example, Hologic offers the Genius AI Detection solution, which also aims to locate lesions in tomosynthesis images and improve cancer detection rates.
DeepHealth does not publish per-provider list pricing for Saige-Dx, and all tiers are custom-quoted. For patients, an Enhanced Breast Cancer Detection (EBCD) service, which utilizes Saige-Dx, may have an out-of-pocket cost, such as $40, as it is not always reimbursed by insurers.

Related Tools

SOPHiA DDM
SOPHiA GENETICS
Oncology AI
SOPHiA DDM™ is an AI-driven and cloud-powered platform that helps clinicians generate real-time, actionable insights for patients with cancer and rare disorders by analyzing complex genomic, radiomic, and multimodal data.
CerviCARE AI
NTL Healthcare
OB/GYN AI
CerviCARE AI is an AI-powered cervical cancer screening system that analyzes smartphone images of the cervix to predict findings, aiming for early detection.
Lumonus AI
Lumonus
Clinical Decision Support & Reference
Lumonus AI is an AI-powered software that assists healthcare providers with prescriptions, dosing, and treatment for cancer patients, with a module (Sigma) that suggests treatment protocols based on prior plans for similar patients.
DeepBio DeepDx® Prostate
DeepBio
Oncology AI
DeepDx® Prostate leverages deep learning to standardize prostate cancer diagnostics by detecting abnormalities in digital slides with high precision, providing automated Gleason grading, tumor quantification, and tumor length measurements.
AIRA Matrix AI Solutions
AIRA Matrix
Lab & Diagnostics
AIRA Matrix offers AI solutions to improve efficiency and diagnostic accuracy in pathology lab workflows, primarily for prostate and breast cancer, with services like DPaaS and predictive toxicology.
Surgical Reality Viewer
Surgical Reality
Oncology AI
Surgical Reality offers CE- and FDA-certified AI-powered 3D medical imaging and surgical planning software that transforms CT scans into patient-specific 3D models for thoracic surgery, enhancing precision in complex lung procedures.

See all Oncology AI tools →

More from DeepHealth

Saige-Density (2.5.0)
DeepHealth, Inc.
Oncology AI
Saige-Density is an FDA-cleared AI software by DeepHealth for automated breast density assessment in mammography, aiding radiologists in consistent and accurate breast tissue categorization.
Saige-Q
DeepHealth, Inc.
Oncology AI
Saige-Q is an FDA-cleared AI software by DeepHealth that processes mammograms to prioritize suspicious cases for radiologists, enhancing workflow efficiency and supporting early breast cancer detection.

View company profile →

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

Investors who backed Saige-Dx

Funded through the company that built this tool.

AI Tool Finder
AI-powered search. Results may not be comprehensive.