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.

Key Terms

software as a medical device (samd) medical

Software as a medical device (SaMD) is software that performs medical tasks—such as detecting disease, monitoring health, or recommending treatment—without being part of a specific piece of medical hardware. Investors care because SaMD must meet safety and regulatory standards and compete for payment and insurance coverage, which affects how quickly it can be adopted, how much revenue it can generate, and the legal and commercial risks involved; think of it like an app that needs government approval before hospitals and patients can use it widely.

510(k) clearance regulatory

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

picture archiving and communication systems (pacs) technical

Picture archiving and communication systems (PACS) are digital platforms that store, organize and transmit medical images such as X‑rays, MRIs and CT scans, replacing film and manual handling. They matter to investors because PACS can speed diagnosis, enable remote consultations, reduce operating costs and improve clinic workflow, so adoption or upgrades can influence healthcare providers’ revenues, efficiency and capital spending.

electronic medical records (emr) technical

Electronic medical records (EMR) are digital versions of a patient’s paper chart used by clinics and hospitals to record diagnoses, treatments, test results, and prescriptions—think of it as a secure, searchable digital filing cabinet for a patient’s care history. Investors care because EMRs affect how efficiently health providers operate, influence costs, enable or block new services, and carry regulatory and data-security risks that can materially change a healthcare company’s revenue and expenses.

centers for medicare and medicaid services (cms) regulatory

The Centers for Medicare & Medicaid Services (CMS) is a U.S. federal agency that runs the country’s major public health insurance programs and sets rules for how providers get paid and how medical products are covered. Investors care because CMS decisions on coverage, payment rates, and rules can change how much revenue healthcare companies earn—think of CMS like a giant client or regulator whose pricing and coverage choices can make or break a product’s market.

medicare outpatient prospective payment system (opps) regulatory

Medicare Outpatient Prospective Payment System (OPPS) is the federal program that sets fixed, standard payments Medicare will make for most services delivered in hospital outpatient settings, like clinics and same-day surgery. Think of it as a public price list or menu for outpatient care; it matters to investors because those set rates directly affect hospital and clinic revenue, profitability, and cash flow, and can change competitive dynamics and investment risk in healthcare businesses.

u.s. preventive services task force (uspstf) medical

The U.S. Preventive Services Task Force (USPSTF) is an independent panel of medical experts that reviews evidence and issues recommendations on preventive health services—like screenings, counseling, and preventive medications. Investors watch USPSTF guidance because its recommendations can change which tests or treatments are widely covered by insurers and used in clinical practice, similar to how a recipe change can shift demand for certain ingredients and alter market size for related products.

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• 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.

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)-- Regulatory News:

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 (ISIN: FR0011049824, 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.

These forward-looking statements can often be identified by the words "expects," "anticipates," "believes," "intends," "estimates" or "plans" and any other similar expressions. Although Median's management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

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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MEDIAN TECHNOLOGIES
Emmanuelle Leygues
VP, Corporate Marketing & Financial Communications
+33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com

Press – MAARC
Bruno Arabian
+33 6 87 88 47 26
bruno.arabian@maarc.fr
Nicolas Entz
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nicolas.entz@maarc.fr

Investors - SEITOSEI ACTIFIN
Ghislaine Gasparetto
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ghislaine.gasparetto@seitosei-actifin.com

U.S. media – TODD STEIN COMMUNICATIONS
Todd Stein
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todd@toddsteincommunications.com

Source: Median Technologies