Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) candidates for early cancer diagnostics, and a globally leading provider of AI analyses and imaging services for oncology drug developers, today announced that it will attend the Radiological Society of North America (RSNA) 2024 Annual Meeting in Chicago, IL, USA, from Dec. 1-5. Median iCRO and eyonis™ teams will welcome interested parties at Booth #5442, AI Showcase, South Hall, Level 3, from December 1-4 (technical exhibits dates).
The Company will share the latest developments for eyonis™ Lung Cancer Screening (LCS) Software as a Medical Device (SaMD) as well as the most recent advances for iCRO central and AI-powered oncology trial imaging services for pharmaceutical companies.
Median reported in August that its investigational lung cancer diagnostic SaMD, eyonis™ LCS, met all primary and secondary endpoints with statistical significance in REALITY (Clinicaltrials.gov identifier: NCT0657623), the first of the two pivotal eyonis™ LCS clinical studies. This impressive result was achieved despite the inclusion of many challenging Low Dose Computed Tomography (LDCT) images. Median recently held a webinar on the REALITY data featuring two globally leading U.S. pulmonologists.
“We are pleased to present the eyonis™ LCS data at RSNA. The recently reported REALITY study data suggest that eyonis™ LCS may well be a game changer, significantly improving early diagnosis and allowing for life-saving earlier intervention and broader screening access. Our diagnostic device may be a critical catalyst facilitating global implementation of these lifesaving screening programs. Based on our strong data, we are now looking towards our filings for marketing authorization, in both the US and Europe, in H1 2025, as soon as we receive and report the data from RELIVE, our second pivotal study in Q1 2025,” said Fredrik Brag, CEO of Median Technologies.
Median eyonis™ team will present at RSNA:
- Scientific Poster Presentation: “Performances of an End-to-End AI/ML CADe/CADx SaMD for Nodule Detection and Characterization in Lung Cancer Screening on an Independent Cohort Compared to Radiologists.”
Session: Chest Imaging (T2-SPCH-2)
Scientific poster discussion on Tuesday, December 3rd, 9:00 AM – 9:30 AM CST
Learning Center, East, Level 3
- Industry Presentation: “New Horizons in the Fight Against Lung Cancer: From Design to Regulatory Filing. Discover How eyonis™ LCS, Median Technologies’ AI-based SaMD, Can Catalyze Lung Cancer Screening Implementation.”
Session: AI-Theater Presentation (IT5-AI105)
Tuesday, December 3rd, 12:30 PM – 12:50 PM CST
AI Theater, Booth 5536, South Hall, Level 3
About eyonis™ LCS: eyonis™ Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic device that uses machine learning to help analyze imaging data generated with low dose computed tomography (LDCT) to diagnose lung cancer at the earliest stages, when it can still be cured in many patients. eyonis™ LCS has been classified by regulators as “Software as a Medical Device”, or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY ((Clinicaltrials.gov identifier: NCT0657623) (successfully completed)) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in 2025. Separately, Median’s AI technology is being sold and deployed across cancer indications, via Median’s iCRO business unit, to companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.
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 2024 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 2024 Annual Meeting, visit https://www.rsna.org/annual-meeting
About Median Technologies: Pioneering innovative imaging solutions and 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 medical devices (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.
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