Peer-reviewed scientific presentation: "Rethinking Lung Cancer Screening: Longitudinal AI/ML Diagnostics beyond Nodule Size Growth”

AI Theater Presentation: "eyonis® LCS: Transforming Lung Cancer Screening Through AI-Powered Early Detection & Diagnosis”

Median iCRO & eyonis® teams will be at booth #5438, AI Showcase, South Hall, Level 3, McCormick Place

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--

Regulatory News:

Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced that it will attend the Radiological Society of North America (RSNA) 2025 Annual Meeting in Chicago, Il, USA, McCormick Place, from Nov 30-Dec. 4, 2025. Median iCRO and eyonis® teams will welcome interested parties at Booth #5438, AI Showcase, South Hall, Level 3, from Nov 30 - Dec 3 (technical exhibits dates).

The Company will share the latest developments for eyonis® Lung Cancer Screening (LCS) SaMD as well as the most recent advances for iCRO central and AI-powered oncology trial imaging services for pharmaceutical companies.

eyonis® LCS has been designed to transform lung cancer screening and address two critical clinical challenges—improving diagnostic accuracy and increasing program efficiency. It has been evaluated in two pivotal studies required for marketing approvals in the U.S. and Europe, both of which have been successfully completed: REALITY (ClinicalTrials.gov ID: NCT06576232) and RELIVE (ClinicalTrials.gov ID: NCT06751576). Based on these data, Median Technologies submitted its U.S. 510(k) clearance application for eyonis® LCS on May 13, 2025, and its European CE mark application on June 30, 2025. eyonis® LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet commercially available in the U.S. or Europe.

“We are excited to share the latest eyonis® LCS data with the global radiology community at the RSNA 2025 Annual Meeting. eyonis® LCS enables earlier diagnosis, streamlines workflows, promotes program adherence, and ultimately supports better patient outcomes. Our Software as a Medical Device is poised to be a key driver in accelerating the global adoption of lifesaving screening programs. In the United States, lung cancer screening is already established, and procedures that leverage AI for quantitative tissue analysis on low-dose CT scans currently benefit from a reimbursement of $650 for each use. Across Europe, national initiatives are gaining momentum to implement similar programs, with Germany being the latest example as it prepares to launch its organized screening program in April 2026,” said Thomas Bonnefont, COO and CCO eyonis® at Median Technologies.

Median eyonis® team will present at RSNA:

Scientific Presentation: "Rethinking Lung Cancer Screening: Longitudinal AI/ML Diagnostics beyond Nodule Size Growth”

Scientific presentation on Wednesday, December 3rd, 3:00 PM – 4:00 PM CT

Session: W7-SSCH07 Chest Imaging (Nodules)

South Building, Level 5, room S501

AI Theater Presentation: “eyonis® LCS: Transforming Lung Cancer Screening Through AI-Powered Early Detection & Diagnosis”

Presentation on Sunday, November 30, 12:30 PM - 12:50 PM CT

Session: AI-Theater Presentation (IT5-AI105)

AI Theater, Booth #5536, South Hall, Level 3

About eyonis® LCS: eyonis® Lung Cancer Screening (LCS) is an artificial intelligence AI-based computer aided detection and diagnosis (CADe/CADx) system, or Software as a Medical Device (SaMD) that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT). eyonis® LCS empowers radiologists to diagnose lung cancer at its earliest, most treatable stages—when curative options remain possible for many patients. eyonis® LCS has been the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (Clinicaltrials.gov ID: NCT06576232) and RELIVE (Clinicaltrials.gov ID: NCT06751576), both of which have been successfully completed. Based on these pivotal data, Median Technologies submitted U.S. application for 510(k) clearance of eyonis® LCS on May 13th, 2025, and European application for CE mark on June 30th, 2025. eyonis® LCS is currently under review for FDA 510(k) clearance and CE marking and is not yet for sale in the US and in Europe.

About RSNA Annual Meeting: The Radiological Society of North America Annual Meeting is the largest medical imaging conference in the world, featuring over 300 educational courses and more than 2,800 scientific presentations covering every subspecialty. RSNA 2025 is expecting approximately 50,000 medical imaging professionals, representing over 120 countries. RSNA hosts the largest medical equipment exhibition, featuring products and services from almost 700 manufacturers, suppliers and developers from innovative startups to industry giants. For more information about the RSNA 2025 Annual Meeting, visit https://www.rsna.org/annual-meeting

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 . 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.

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Source: Median Technologies