eyonis® LCS
Overview
Median Technologies is a pioneer in applying artificial intelligence technologies to medical imaging, developing and marketing eyonis®, a suite of AI-powered Software as a Medical Device (SaMD) for the early diagnosis of solid tumor cancers. eyonis® LCS is specifically designed for lung cancer screening procedures. The company’s mission is to shift the imaging diagnostic paradigm by designing innovative AI/ML tech-based SaMDs, supporting radiologists and healthcare professionals worldwide in screening, early diagnosis, and treatment of cancer. Their vision is to establish eyonis® as a Standard-of-Care (SoC) to reduce the cancer burden by helping identify disease at the earliest stage, allowing better care while avoiding unnecessary medical procedures and reducing healthcare costs. Median Technologies also provides central imaging services and AI-based image analysis for oncology clinical trials in the biopharmaceutical industry through its iCRO business.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI/ML-powered computer-aided detection and diagnosis (CADe/CADx)
- Early detection, localization & diagnosis of solid & part solid pulmonary parenchymal nodules (4-30 mm Longest Average Diameter) on Chest Low-Dose Computed Tomography (LDCT) images.
- Generates DICOM file result reports, PACS available & compatible with every radiologist's viewer.
- Lists all probably benign, suspicious, very suspicious lung nodules present in LDCT image series.
- Scores nodules individually by giving a malignancy score & providing a Likelihood of Malignancy (LOM%) from 1% to 93%.
- 93.3% sensitivity in detecting cancer cases.
- 92.4% specificity in identifying benign cases.
- 99.9% Negative Predictive Value (NPV).
- 66% False Negative reduction.
- 68% False Positive reduction.
Use Cases
- Lung cancer screening programs.
- Aiding radiologists in detecting and characterizing parenchymal pulmonary nodules.
- Supporting clinical decision-making and patient follow-ups.
- Reducing inter-reader variability in lung cancer screening.
- Improving the efficiency and consistency of lung cancer screening programs.
What Physicians Need to Know
Leverage eyonisu00ae LCS to enhance your diagnostic accuracy in lung cancer screening, particularly for early-stage detection and characterization of pulmonary nodules on LDCT scans. The high negative predictive value can increase confidence in ruling out cancer, potentially reducing unnecessary follow-up procedures. Integrate it into your existing PACS workflow for seamless operation and consider its potential to standardize your screening program and manage increasing screening volumes efficiently.
eyonisu00ae LCS offers direct integration with hospital PACS for streamlined workflow. Additionally, it has a non-exclusive distribution agreement with Tempus AI, integrating into their Pixel platform, which provides advanced analysis and reporting from radiology images. This allows for enhanced clinical decision-making and patient management within an established enterprise workflow.
Details
| Category | Oncology AI |
| Pricing | Unknown — unknown |
| Deployment | Cloud-based or institution local hosting. DICOM images are collected via the eyonis® Gateway & sent to the eyonis® Cloud for processing. The final result report is then PACS available. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated eyonis® LCS received FDA 510(k) clearance on February 6, 2026, as the first end-to-end detection and diagnosis device specifically targeting lung cancer screenings. It is an AI/ML-powered computer-aided detection and diagnosis (CADe/CADx) Software as a Medical Device. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pulmonology, Radiology |
What the Web Says
eyonisu00ae LCS is an AI/ML-powered Software as a Medical Device (SaMD) developed by Median Technologies for lung cancer screening. It recently received FDA 510(k) clearance in February 2026 and CE marking in July 2026, enabling its commercialization in the U.S. and Europe. The software is designed to assist radiologists in detecting, localizing, and characterizing pulmonary nodules on low-dose CT (LDCT) scans, aiming to improve diagnostic accuracy, reduce false positives and negatives, and streamline clinical workflows. Studies have shown that eyonisu00ae LCS, when used in conjunction with a radiologist, significantly improves diagnostic accuracy compared to radiologists alone.
Overall: PositiveStrengths
- Improves diagnostic accuracy for lung cancer screening.
- Reduces false positives and false negatives, leading to fewer unnecessary procedures and reduced patient anxiety.
- Aids in earlier detection and characterization of lung nodules, potentially leading to improved patient outcomes.
- Enhances workflow efficiency and standardization for radiologists.
- Compatible with existing Picture Archiving and Communication Systems (PACS).
- Potential to reduce healthcare costs by avoiding unnecessary procedures and enabling earlier, more curable diagnoses.
Limitations
- Initial setup can be complex and time-consuming.
- High cost may be a limitation for smaller or mid-sized teams.
- Limited information available from independent tech reviewers, Reddit, G2, and Capterra specifically for eyonisu00ae LCS, as it is a relatively new product to market.
- The device is not yet available for commercial sale in all regions, with CE marking pending in some areas.
Based on reviews from: MyStrategist, AI for Lung Cancer Screening, CancerNetwork, MedTech AI, FDA Clears eyonis LCS for Use in Lung Cancer Screening, Business Wire, Medical Product Outsourcing, Reddit, FirstWord HEALTHTECH, Morningstar, BioSpace, TEM Stock News, GO2 for Lung Cancer - Facebook
Last updated: 2026-09-10
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