Artificial intelligence program, eyonis LCS, demonstrates effectiveness and safety in clinical trial called RELIVE
In the ongoing quest to revolutionize lung cancer screening, Median Technologies, a pioneering French biopharmaceutical company, has announced the successful conclusion of the pivotal study for their AI/ML-based computer-aided detection and diagnosis (CADe/CADx) Software as a Medical Device (SaMD), eyonis Lung Cancer Screening (LCS).
The results of the RELIVE study, presented in the final report, support the intended use for which eyonis LCS was developed. The successful conclusion of these pivotal studies is a crucial prerequisite for regulatory submissions in the United States and Europe.
The development of eyonis LCS SaMD is focused on the United States, Europe, and the rest of the world, aiming to scale up Low Dose CT lung cancer screening programs globally. This AI-based SaMD is designed to aid radiologists in the detection, localization, characterization, and assessment of pulmonary nodules from medical images, ultimately intending to save lives, support medical professionals in completing more screening procedures, and reduce healthcare costs.
The RELIVE study final results demonstrate that Median's eyonis LCS SaMD meets key endpoints, offering statistically significant performance, superior to state of the art, device safety, and efficacy. The successful performance of eyonis LCS SaMD is a testament to Median Technologies' commitment to delivering innovative solutions in the field of medical technology.
The regulatory landscape for AI-enabled SaMD is complex and fragmented, with different expectations per jurisdiction. Manufacturers must demonstrate clinical validation tailored to these varying requirements, build transparency and explainability into AI models, implement human oversight mechanisms, plan for ongoing post-market surveillance and AI model update controls, comply with privacy laws such as the EU’s GDPR, and engage proactively with regulators.
For instance, the European Union (EU) classifies healthcare AI as high-risk, imposing stringent requirements for transparency, human oversight, and post-market surveillance. The EU’s Medical Device Regulation (MDR) continues to evolve for AI-specific challenges, and compliance with the General Data Protection Regulation (GDPR) regarding data privacy is essential.
In the United States, the U.S. Food and Drug Administration (FDA) is pioneering regulatory pathways for AI-enabled medical devices. It has authorized over 900 such systems as of August 2024. The FDA encourages use of a Predetermined Change Control Plan (PCCP), which preauthorizes a protocol for future AI software updates without needing new submissions for each change, provided the updates follow rigorous validation, testing, cybersecurity, labeling, and monitoring standards.
The UK's Medicines and Healthcare products Regulatory Agency is integrating recommendations from the Regulatory Horizons Council on AI medical devices regulation. It focuses on developing standards, guidance, and enhanced post-market surveillance measures effective June 2025. The UK has also piloted a regulatory sandbox ("AI airlock") to test challenges of AI/Software as a Medical Device regulation in collaboration with the NHS.
Asia, including Japan, Singapore, and South Korea, are developing specialized AI healthcare frameworks balancing innovation with patient protection, recognizing the need for tailored regulatory environments distinct from Western paradigms.
Median Technologies expects eyonis LCS' FDA 510(k) clearance in Q3 2025 and CE marking in Q1 2026. The US FDA filing for eyonis LCS is on track for formal submission in May 2025, followed by filing for CE marking in Europe in June. Fredrik Brag, CEO of Median Technologies, stated that they have achieved the efficacy and safety goals for the intended use and marketing of eyonis LCS to aid diagnose lung cancer.
In the coming quarters, Median Technologies intends to present pivotal study results, including RELIVE study data, at upcoming medical and scientific conferences. With these achievements, Median Technologies is poised to make significant contributions to the global fight against lung cancer.
- The development of Median Technologies' eyonis Lung Cancer Screening (LCS) is focused on the utilization of digital health technology, aiming to revolutionize lung cancer screening worldwide.
- The successful conclusion of the RELIVE study provides evidence for the product's intended use, and the superior performance of eyonis LCS over existing technology underscores its potential to impact patient care.
- The regulatory landscape for AI-based medical devices is varied, with the European Union mandating stringent requirements for transparency and human oversight, the US FDA implementing a Predetermined Change Control Plan for updates, and Asia developing specialized AI healthcare frameworks for patient protection.
- Median Technologies plans to present pivotal study results at upcoming medical and scientific conferences, demonstrating the company's commitment to health-and-wellness innovations and its significant role in the global fight against cancer using advanced science and technology, including artificial intelligence.
