- eyonis® LCS commercial launch is ongoing in U.S. following FDA 510(k) clearance
- CE-marking regulatory process is on-going with a decision expected in Q2 2026 that could trigger commercial rollout of eyonis® LCS across Europe this year
- Median eyonis® team will be at Booth #AI-16, AI Exhibition, Expo X1, to highlight clinical impact of eyonis® LCS in lung cancer screening
- eyonis® LCS will also be featured in two AI Lightning Talk industry sessions and one research session
SOPHIA ANTIPOLIS, France–(BUSINESS WIRE)–Regulatory News:
Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered Software as Medical Devices (SaMDs) for early cancer diagnosis and a global leader in AI-based image analysis and central imaging services for oncology drug development, today announced that it will feature eyonis® LCS at the European Congress of Radiology (ECR) 2026 in Vienna, March 4–6, 2026.
The Median eyonis® team will welcome attendees at Booth #AI-16, AI Exhibition, Expo X1, from March 4 to March 7 (technical exhibition dates), to present the latest developments related to eyonis® Lung Cancer Screening (LCS), its AI-powered Software as a Medical Device (SaMD).
“Earlier this month, Median Technologies received FDA 510(k) clearance for eyonis® LCS, marking a pivotal milestone in our mission to transform lung cancer screening through cutting-edge AI innovation. As we work toward the obtention of our CE marking for eyonis® LCS, with a decision expected in Q2 this year, we are preparing for the next step: bringing our technology into clinical practice across Europe and empowering clinicians with new tools to diagnose lung cancer earlier and more effectively,” said Thomas Bonnefont, COO and CCO of the eyonis® Business Unit at Median Technologies.
On February 9, 2026, Median announced that eyonis® LCS, its AI-based CADe/CADx SaMD for lung cancer screening, received FDA 510(k) clearance for detection and characterization of parenchymal pulmonary nodules in low-dose CT (LDCT) scans. eyonis® LCS is the only medical device software capable of detecting and characterizing lung cancer in LDCT scans, achieving 93.3% sensitivity, 92.4% specificity, and 99.9% negative predictive value (NPV) (manufacturer values calculated on a lung cancer screening reference population). eyonis® LCS helps clinicians identify suspicious findings at early stages, enhancing the efficiency and consistency of lung cancer screening programs.
Median continues to advance along the European regulatory pathway for eyonis® LCS and anticipates obtaining CE marking in Q2 2026.
“We are thrilled to showcase our innovative software as a medical device, eyonis® LCS—a Class IIb end-to-end Medical Device Software (MDSW)—to the European radiology community gathered in Vienna for ECR. eyonis® LCS is designed to assist radiologists in the detection and characterization of pulmonary parenchymal nodules and represents a significant leap forward in lung cancer screening,” Bonnefont added.
Median’s eyonis® team will also hold multiple presentations at ECR:
-
Industry Presentation: “eyonis® LCS: redefining Lung Cancer Screening with AI”
Presenter: Stefania Baraghini, VP Marketing eyonis® – Median Technologies
Session AI-IND 3 – AI Lightning Talks 3
Wednesday, March 4 – 13:30 – 14:30 CET
AI Theatre, ACV Building Level -2
-
Industry Presentation: “eyonis® LCS: Transforming Lung Cancer Screening through AI-powered detection & diagnosis”
Presenters: Stefania Baraghini, VP Marketing eyonis® – and Laurence Boy-Machefer, VP Regulatory Affairs eyonis® – Median Technologies
Session AI-IND 8 – AI Lightning Talks 8
Thursday, March 5 – 16:00 – 17:00 CET
AI Theatre, ACV Building Level -2
-
Research Presentation: “AI-Assistance Improving Lung Nodule Risk Assessment in Lung Cancer Screening: Results from RELIVE, A Multi-Reader Multi-Case Study to Evaluate the Performance of an End-to-End AI/ML-based CADe/CADx”
Presenter: Charles Voyton, Associate Director Clinical Development – eyonis®
Research Presentation Session: Artificial Intelligence and Imaging Informatics
RPS 105 – Exploring the AI-radiomics interface in lung cancer
Wednesday March 4 – 08:00 – 09:30 am CET
ACV Research Stage 6, Vienna, Austria
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.
Contacts
MEDIAN TECHNOLOGIES
Emmanuelle Leygues
VP, Corporate Marketing & Financial Communications
+33 6 10 93 58 88
[email protected]
Press – MAARC
Bruno Arabian
+33 6 87 88 47 26
[email protected]
Nicolas Entz
+33 6 33 67 31 54
[email protected]
Investors – SEITOSEI ACTIFIN
Ghislaine Gasparetto
+33 6 85 36 76 81
[email protected]
U.S. media – TODD STEIN COMMUNICATIONS
Todd Stein
+1 510.417.0612
[email protected]
