Products

RevealDx
RevealDx
Clinical Decision Support & Reference
RevealAI-Lung is an AI-powered software that assists physicians in the early and accurate characterization of lung nodules from CT scans.

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About RevealDx

RevealDx is a Seattle-based healthcare AI company dedicated to dramatically improving lung cancer outcomes through advanced, radiomics and AI-enabled decision support software. Their flagship product, RevealAI-Lung, is designed to assist physicians in the non-invasive diagnosis and management of lung nodules. The software analyzes chest CT scans to produce a Malignancy Similarity Index (mSI) score, which helps radiologists make more informed follow-up recommendations and supports earlier cancer diagnosis.

RevealAI-Lung integrates directly into Picture Archiving and Communication Systems (PACS), aiming to streamline radiology workflows with a single-click operation that delivers results within seconds. The company emphasizes that its patented approach provides improved stability across image types and offers transparency in predictions by extracting local predictive value from three-dimensional analysis of lesions, combined with an analysis of the broader lung and chest. This technology has been validated in clinical trials involving over 1,500 patients from various cohorts, demonstrating improvements in radiologist performance and a reduction in false positives. RevealAI-Lung has received FDA clearance in the U.S., MDR certification in Europe, and TGA approval in Australia, and is reimbursable under Medicare in the U.S.

Focus Areas

AI-enabled lung cancer decision support radiomics lung nodule characterization medical imaging AI oncology healthtech

Business Intelligence

Key Investors4DMedical, Westway Capital, A-Level Capital, Alliance of Angels, Frontier Angels, Frost Data Capital, Life Science Angels
Partnerships4DMedical, Sirona, contextflow, Riverain, Fuji PACS, TriHealth
AcquisitionsMindshare Medical (acquired by Precision Medical Ventures, which then became RevealDx)
TechnologyAI-enabled software, radiomics, cloud-native (implied by software focus and integrations)
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Specialization
RevealDx specializes in AI-enabled lung cancer decision support, radiomics, and lung nodule characterization to improve lung cancer outcomes through non-invasive diagnosis.
Key Product
Their flagship product, RevealAI-Lung, provides a 'Malignancy Similarity Index' (mSI) for each lung nodule found in a chest CT exam.
Technology Focus
The company utilizes proprietary analytics, patented algorithms, 3D analysis of lesions, and ensemble classification techniques coupled with radiomic features.
Clinical Validation & Regulatory
RevealAI-Lung has been extensively validated in clinical trials and research, demonstrating improved early cancer detection and reduced false positives. It holds FDA clearance, European MDR certification, Health Canada approval, and Australian TGA approval.
Efficiency & Cost Savings
The software aims to reduce unnecessary invasive procedures like biopsies and surgeries, leading to significant cost savings and quicker diagnoses.
Physician Tip

For physicians, RevealDx's RevealAI-Lung offers actionable radiomic insights with a Malignancy Similarity Index (mSI) that can enhance confidence in lung nodule assessments. The system integrates directly into Picture Archiving and Communication Systems (PACS) with single-click operation, providing results within seconds and minimizing disruption to existing workflows. This can lead to more effective triage of lung nodules, earlier cancer detection, and a reduction in unnecessary procedures, ultimately improving patient care and outcomes.

RevealDx's RevealAI-Lung is designed for seamless integration into existing clinical workflows, particularly with PACS. They have established partnerships and integrations with companies like Sirona Medical, Riverain Technologies, Azra AI, and 4DMedical, allowing for enhanced lung nodule detection, characterization, and a comprehensive cardiopulmonary imaging ecosystem.

Products by RevealDx

1 product in the directory

RevealDx
RevealDx
Clinical Decision Support & Reference
RevealAI-Lung is an AI-powered software that assists physicians in the early and accurate characterization of lung nodules from CT scans.

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Press & Coverage

Latest Medtech News
RevealDx partners with 4DMedical to expand AI lung cancer diagnostics globally
RevealDx has partnered with 4DMedical, securing a $3.4 million strategic investment to globally distribute its AI-powered RevealAI-Lung platform, which is FDA-cleared, MDR-certified, and TGA-approved. This collaboration aims to expand access to the technology across the US, Europe, Australia, and New Zealand, helping clinicians identify malignant lung nodules earlier.
2026-08
AuntMinnie
RevealDx secures distribution deal, $3.4M investment from 4DMedical
RevealDx has entered a distribution agreement with 4DMedical, which includes a $3.4 million strategic investment, to broaden the reach of its RevealAI-Lung software in the U.S., Europe, Australia, and New Zealand. The software uses a Malignancy Similarity Index to characterize lung nodules on CT scans and assist radiologists in making follow-up recommendations.
2026-08
Imaging Technology News
RevealDx Gets FDA Clearance for RevealAI-Lung
RevealDx announced FDA clearance for its RevealAI-Lung software in February 2026, following its MDR certification in November 2025. This AI-powered technology helps characterize lung nodules by providing a Malignancy Similarity Index (mSI) to aid radiologists in cancer diagnosis.
2026-02
Medical Device Network
FDA clears RevealDX's AI lung nodule diagnostic
RevealDx received U.S. FDA clearance for RevealAI-Lung, an AI-based software that assesses the risk of malignancy in lung nodules from CT scans. The software assigns a Malignancy Similarity Index (mSI) score to help radiologists make more informed follow-up recommendations.
2026-02
RevealDx (Press Release)
Azra and RevealDx Announce Partnership
Azra AI and RevealDx announced a new partnership to integrate RevealDx's RevealAI-Lung technology, which provides a Malignancy Similarity Index (mSI) for lung nodule characterization, into Azra AI's oncology workflow automation platform. This collaboration aims to improve early cancer detection and streamline patient care.
2026-05
RevealDx (Press Release)
RevealDx Receives MDR Certification for AI Powered Lung Nodule Decision Support
RevealDx announced in November 2025 that it received MDR Certification for its AI-powered lung nodule decision support software. This certification allows the RevealAI-Lung product to be marketed and used clinically in the European Union.
2025-11
contextflow
contextflow targets early lung cancer detection by augmenting ADVANCE Chest CT with malignancy scoring from RevealDx
contextflow released an updated version of its ADVANCE Chest CT tool, now augmented with RevealDx's malignancy scoring feature (mSI) to enhance early lung cancer detection and reduce unnecessary procedures. This integration simplifies lung nodule interpretation by calculating mSI scores before radiologists begin reading the exam.
2024-05
RevealDx (Press Release)
Rebranding of Mindshare Medical to RevealDx
Precision Medical Ventures announced the rebranding of Mindshare Medical to RevealDx in September 2021, focusing the company on lung cancer diagnosis and treatment. RevealDx aims to accelerate the commercialization of its RevealAI-Lung software, which is designed to improve diagnostic precision and reduce healthcare costs.
2021-09

Frequently Asked Questions

RevealDx utilizes AI to provide decision support for lung cancer by analyzing medical images, particularly CT scans, to characterize lung nodules. Its platform integrates advanced radiomics, extracting quantitative features from these images that may not be visible to the human eye, to aid in the early detection and risk stratification of lung cancer. This approach aims to enhance diagnostic accuracy and guide more personalized treatment pathways for patients.
RevealDx's AI-enabled technology for lung nodule characterization offers a more objective and quantitative assessment compared to traditional, often subjective, methods. The company has conducted studies demonstrating the efficacy of its solutions in accurately classifying lung nodules as benign or malignant, aiming to reduce unnecessary biopsies and improve patient outcomes. Clinical evidence, including peer-reviewed publications and presentations, supports the performance and potential benefits of their AI algorithms.
RevealDx offers AI-powered software platforms designed to integrate seamlessly into existing radiology and oncology workflows. These products focus on automating and enhancing the analysis of medical images for lung cancer screening and diagnosis. By providing rapid and precise insights, RevealDx's solutions aim to streamline the decision-making process, reduce physician workload, and improve the overall efficiency of oncology departments.
RevealDx prioritizes data privacy and adheres to stringent regulatory compliance standards, including HIPAA and GDPR, to protect patient information. The company's medical imaging AI solutions are developed and deployed with a strong emphasis on data security and ethical AI practices. RevealDx actively pursues and maintains necessary regulatory clearances, such as FDA approval, to ensure its products meet the highest standards for safety and efficacy in clinical use.
RevealDx typically offers flexible pricing models that can be tailored to the specific needs and scale of healthcare organizations, often based on usage or licensing agreements. The company provides comprehensive technical support, including implementation assistance, ongoing maintenance, and dedicated customer service. RevealDx also offers thorough training programs for physicians and administrators to ensure effective integration and utilization of their AI solutions within clinical workflows.
RevealDx actively collaborates with leading healthtech companies, medical device manufacturers, and prominent academic research institutions to advance its AI technology and expand its market reach. These partnerships often focus on research and development, clinical validation, and integration of their solutions into broader healthcare ecosystems. RevealDx's long-term vision emphasizes continuous innovation, strategic alliances, and a commitment to improving lung cancer outcomes globally, ensuring sustained growth and stability in the evolving healthtech landscape.

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