Median Technologies Announces Collaboration With Tempus to Expand Access to eyonis® LCS Software as a Medical Device in the United States

Key Terms

software as a medical device medical

Software as a medical device (SaMD) is standalone software that performs medical functions — such as diagnosing, monitoring, predicting, or guiding treatment — without needing to be part of a physical medical gadget. For investors it matters because SaMD faces specific regulatory approval, liability and reimbursement rules, can scale rapidly with lower manufacturing costs than hardware, and often drives recurring revenue and data-privacy risks similar to a digital service replacing a physical tool.

samd medical

Software as a Medical Device (SaMD) is standalone software that performs medical functions—such as diagnosing, monitoring, or suggesting treatment—without being part of a physical medical device. Think of it like a smartphone app acting as a thermometer or decision assistant: its accuracy and reliability affect patient outcomes and can trigger regulatory approval, liability, and reimbursement issues that materially influence a company’s revenues, costs, and investment risk.

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.

ce-marked regulatory

CE-marked indicates a product meets European Union requirements for safety, performance and legal compliance, allowing it to be sold across the European Economic Area. For investors, a CE mark is like a passport or safety stamp — it reduces regulatory and market-entry risk, can speed sales and adoption across many countries, and signals the maker completed required testing and documentation, which can affect revenue forecasts and valuation.

low-dose ct scans medical

Low-dose CT scans are medical imaging tests that take a series of detailed X-ray pictures of the body using much less radiation than a standard CT, often used for screening rather than diagnosis. For investors, they matter because lower radiation and faster, cheaper scans can increase screening uptake, drive demand for equipment and software, and influence reimbursement and market growth—think of them as a more affordable, lower-risk version of a high-resolution photo used to catch early problems.

negative predictive value medical

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

ai-enabled technical

AI-enabled describes a product, service, or process that uses artificial intelligence—software that learns from data and makes decisions or predictions—as a core feature rather than a minor add-on. For investors it matters because AI-enabled offerings can boost productivity, lower costs or unlock new revenue streams; like adding a smart autopilot to a routine task, they can change a company's growth potential and competitive edge while also bringing higher upfront investment needs and distinct regulatory or ethical risks.

caDe/cadx medical

CADe (computer-aided detection) and CADx (computer-aided diagnosis) are software tools that analyze medical images: CADe flags potential abnormalities for a human to review, while CADx offers a suggested interpretation or probability of disease. For investors, they matter because regulatory clearance, clinical acceptance, reimbursement and integration into hospital workflows determine commercial uptake, revenue potential and legal risk—akin to a high-quality sensor versus a second expert opinion in healthcare.

The collaboration follows FDA 510(k) clearance for eyonis^® LCS and aims to integrate high-performance lung cancer screening detection and diagnosis device into the clinical workflow through the Tempus Pixel platform.

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

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 its non-exclusive distribution agreement with Tempus AI, Inc. (NASDAQ: TEM) a technology company leading the adoption of AI to advance precision medicine.

Under the agreement, Tempus AI will distribute eyonis^® LCS to U.S. imaging providers through the Tempus Pixel platform and support implementation, customer onboarding, and workflow integration. Tempus Pixel¹ is an FDA-cleared, CE-marked AI-enabled solution that offers advanced analysis, tools, and automated reporting from radiology images to help providers accurately track and quantify lesions. It aims to aid providers in making informed diagnostic and disease management decisions.

Median announced on February 9, 2026, that eyonis^® LCS, its AI-based CADe/CADx Software as a Medical Device (SaMD) for lung cancer screening has received FDA 510(k) clearance. eyonis^® LCS is the only device capable of detecting and characterizing lung cancer in low-dose CT scans (LDCT), with 93.3% sensitivity, 92.4% specificity, and 99.9% Negative Predictive Value (NPV) (manufacturer values calculated on a lung cancer screening reference population), helping clinicians identify suspicious findings earlier and improve the efficiency and consistency of lung cancer screening programs.

Fredrik Brag, CEO and Founder of Median Technologies stated: “Activating our distribution collaboration with Tempus AI is a decisive step in bringing eyonis^® LCS to patients at national scale. Tempus AI’s strong leadership in AI-enabled precision medicine, deeply integrated data-technology ecosystem, and strong market presence make them an exceptional partner to drive rapid and high-impact adoption of eyonis^® LCS across the United States.”

Razik Yousfi, Tempus SVP & GM, AI Products added: “We believe AI reaches its full potential when it helps clinicians identify disease earlier and more accurately. By expanding our Pixel platform with sophisticated lung cancer screening AI tools, we are enabling radiologists to manage complex caseloads while prioritizing early-stage detection. Our collaboration with Median Technologies is about more than technology; it’s about improving the standard of care and preventing avoidable deaths through better screening access.”

Revenues generated from the use of eyonis^® LCS will be shared between the parties in accordance with the commercial terms of the partnership. The collaboration builds on the existing NT-APC 1508 reimbursement pathway ($601–$700) and targets the 14.5 million Americans eligible for lung cancer screening.

Median continues to progress along the European regulatory pathway for eyonis^® LCS and anticipates obtaining CE marking in Q2 2026. Under the executed distribution agreement, Tempus AI would support the commercial rollout of eyonis^® LCS across Europe.

Median Technologies announced the signature of the non-exclusive distribution agreement on December 8, 2025, without disclosing the partner’s identity.

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. 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.

About Tempus: Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the expected outcomes and potential benefits of the collaboration with Median Technologies . In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Quarterly Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

¹ Tempus Pixel is manufactured and registered under Arterys Inc., a wholly owned subsidiary of Tempus, for both FDA and CE Mark purposes.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260212874753/en/

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

+33 6 33 67 31 54

nicolas.entz@maarc.fr



Investors - SEITOSEI ACTIFIN

Ghislaine Gasparetto

+33 6 85 36 76 81

ghislaine.gasparetto@seitosei-actifin.com



U.S. media – TODD STEIN COMMUNICATIONS

Todd Stein

+1 510.417.0612

todd@toddsteincommunications.com

Source: Median Technologies