FDA Clearance Sets Stage for U.S. Commercialization of eyonis® LCS Software as a Medical Device for Lung Cancer Screening; Oran Muduroglu Appointed President of Median eyonis Inc.
- Oran Muduroglu, proven medical imaging entrepreneur, to lead U.S. launch of eyonis® LCS
- Established U.S. commercial and clinical infrastructure combined with Medicare reimbursement pathway already in place to support expansion
- Active discussions underway to establish key clinical partnerships to support broad access across U.S. lung cancer screening programs
- Webcasts will be held on February 26, 2026, to discuss the Company's recent achievements and upcoming milestones for eyonis® LCS deployment in the U.S.
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Oran Muduroglu Appointed President of Median eyonis Inc.
Median Technologies (FR0011049824, ALMDT, "Median" or the "Company"), developer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a provider of AI-enhanced and central imaging services for oncology drug developers, today announced the appointment of Oran Muduroglu as President of Median eyonis Inc., Median's U.S. subsidiary. Oran will lead the U.S. launch and scale-up of eyonis® LCS, the Company's AI-powered Software as a Medical Device (SaMD) for lung cancer screening, following U.S. Food and Drug Administration (FDA) 510(k) clearance announced on February 9, 2026. Oran will continue to serve as Executive Chairman of the Board of Directors of Median Technologies while assuming operational leadership of U.S. commercialization.
"With FDA clearance secured, a defined Medicare reimbursement pathway in place, and a uniquely differentiated solution developed through the exceptional scientific and engineering leadership of our colleagues in France, we are entering this launch with strong momentum," said Oran.
Oran continued, "Our focus now is disciplined execution — aligning payers, distribution partners, and providers around a solution that directly addresses one of the key drivers of non-adherence in lung cancer screening. By reducing uncertainty and false positives, we seek to enable earlier diagnosis, improve physician productivity, and strengthen both the clinical and economic performance of screening programs. We believe eyonis® LCS can materially improve patient confidence and engagement and help health systems focus on patients who truly require intervention. That combination of clinical performance and economic value will drive adoption at scale."
A Track Record of Developing and Scaling Transformational Imaging Platforms
Oran brings more than three decades of experience building, engineering, and scaling enterprise imaging and workflow platforms, consistently translating technical innovation into broad U.S. adoption.
He led the sale of Cemax to 3M/Imation in 1995, helping accelerate the transition to modern Picture Archiving and Communication Systems (PACS). He later co-founded Stentor, acquired by Philips in 2005, which became one of the first enterprise platforms enabling fully digital imaging workflows and an early SaaS model in medical imaging, reaching the number two U.S. market position within three years.
Further, as CEO of Medicalis, acquired by Siemens Healthineers in 2017, he led commercialization of a clinical decision support and workflow platform adopted by approximately nine of the top 15 U.S. health systems. In 2018, Alphabet's Verily recruited him to lead development of a value-based care platform supporting physician groups in managing Medicare Advantage risk.
Across these ventures, Oran has led complex national deployments requiring deep Electronic Medical Records (EMR) and PACS interoperability, rigorous product development, disciplined enterprise sales, and alignment with evolving reimbursement models — experience directly relevant to the U.S. launch of eyonis® LCS.
"Oran is a highly respected leader with deep operational rigor and commercialization expertise," said Fredrik Brag, CEO and founder of Median Technologies. "His experience scaling imaging platforms nationally makes him uniquely qualified to lead this next phase of growth."
Coordinated Launch Strategy to Drive Rapid Scale-Up in the U.S.
During development and validation of eyonis® LCS, the eyonis® team built strong awareness and credibility among radiologists, pulmonologists, and oncologists through presentations at major medical congresses and engagement with leading academic centers. Building on this foundation, the Company is actively engaged in discussions to establish key clinical partnerships designed to enable broad access across U.S. lung cancer screening programs.
Following eyonis® LCS' FDA 510(k) clearance announced on February 9, 2026, Median has activated a phased U.S. launch strategy designed for disciplined national expansion. The Company has conducted detailed customer and payor mapping to prioritize regions with strong lung cancer screening volumes and favorable reimbursement dynamics.
To support the launch strategy, Median eyonis Inc. is expanding its U.S.-based commercial and clinical support teams and will deploy a coordinated strategy designed to combine direct enterprise sales, strategic distribution partnerships, and seamless workflow integration.
On February 12, 2026, Median announced the execution of a non-exclusive distribution agreement with Tempus AI (NASDAQ:TEM), a U.S technology company leading the adoption of AI to advance precision medicine. The non-exclusive distribution agreement leverages Tempus' established position in oncology and AI-based precision medicine, and its strong network of healthcare providers, oncologists, and diagnostic centers. Tempus integration of eyonis® LCS into its Pixel platform reinforces the clinical utility of the technology and facilitates adoption via an established entreprise workflow. This collaboration is designed to enhance commercial availability of eyonis® LCS across the U.S.
Median plans to broaden commercial adoption of eyonis® LCS by targeting additional non-exclusive distribution agreements with top-tier imaging and cloud technology partners as well as diagnostics partners.
The launch leverages the existing Centers for Medicare and Medicaid Services' (CMS) reimbursement framework. Following FDA clearance, eyonis® LCS is reimbursable under the New Tech APC pathway, as an initial bridge toward broader and more durable coverage. For 2026, the Medicare Outpatient Prospective Payment System (OPPS) will pay approximately $601–$700 per exam, providing a predictable payment pathway for providers. Approximately 14.5 million Americans meet U.S. Preventive Services Task Force (USPSTF) eligibility criteria for lung cancer screening, supporting substantial adoption potential.
The Company expects its first U.S. sites to be operational in Q3 2026.
Webcasts will be held on February 26, 2026, to discuss the Company's recent achievements and upcoming milestones for eyonis® LCS deployment in the US. Full webcast details will be released in the coming days.
About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median's offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis®, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (TRQX:ALMDTp, ticker: ALMDT)). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements are not historical facts. They include projections and estimates, as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.
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All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained thereon.
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