On September 11, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that the Company will attend the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from Sep. 13-17 (Press release, MEDIAN Technologies, SEP 11, 2024, View Source [SID1234646522]). Median iCRO and eyonis teams will be present to welcome interested parties at Booth #525, Hall 3, from September 13-16 (exhibition dates). The Company will share the most recent advances for iCRO AI-powered clinical trial imaging services as well as latest developments for eyonis Lung Cancer Screening (LCS) Software as Medical Device (SaMD).
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Median eyonis team will present a peer-reviewed poster presentation of the full positive results of the independent verification study for Median proprietary SaMD eyonis Lung Cancer Screening (LCS). Preliminary results of the study were communicated on January 17, 2024. This independent verification study is part of a process in medical device development required by regulators; it ensures devices meet stringent regulatory standards and defined product requirements. The independent verification study was completed prior to the pivotal independent standalone validation study, REALITY, for which highly positive results were communicated on August 29, 2024.
Poster presentation: #1192P: Optimizing Lung Cancer Screening: Independent Verification of an AI/ML Computer-Aided Detection and Characterization Software as Medical Device
Authors: S. BODARD1, C. M VOYTON2, P. BAUDOT2, E. GEREMIA2, P. SIOT2, G. DE BIE2, V. LE2, D. FRANCIS2, B. RENOUST2, B. HUET2 – [1] Université de Paris Cité, AP-HP, Paris, France, [2] Median Technologies, Valbonne, France.
Onsite display date: Sep 15, 2024
Poster Session: New Diagnostic Tools
About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered computer aided diagnostic device that uses machine learning (ML) to help analyze imaging data generated with low-dose computed tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed – Clinicaltrials.gov identifier: NCT0657623) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit, to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.
About ESMO (Free ESMO Whitepaper): The annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress is one of the most widely attended and highly regarded global oncology conferences. It attracts clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world for presentations and discussions on the latest cutting-edge research from academia and industry. For more information about the ESMO (Free ESMO Whitepaper) Congress 2024, visit View Source