(BFM Bourse) – The Côte d’Azur company specializing in artificial intelligence applied to medical imaging has submitted a dossier to the American health agency to have its software/medical device iBiopsy approved, which has made it possible to characterize pulmonary nodules with exceptional accuracy in a study of nearly 1700 patients.
The Sophia Antipolis (Valbonne) firm Median Technologies recently submitted a dossier to the American Food and Drug Administration seeking the opinion of the agency on the choice of a regulatory category for its software/medical device iBiopsy, in for future certification.
The filing of the file, administratively designated “513(g)”, does not in itself constitute a request for marketing authorization. This is a procedure put in place to allow companies to choose the best classification, in particular for innovative products at the crossroads of several categories, and therefore determine the best way of regulatory access. Typically, producers use it to know whether to go through the classic procedure for medical devices, known as “510(k)”.
The FDA aims to provide a recommendation after a 60-calendar-day review of a 513(g) submission.
In other words, this first regulatory filing marks the start of Median’s interactions with the US FDA. “The FDA recommendation will allow us to determine the shortest and most efficient regulatory path to bring our product to the US market,” said Fredrik Brag, CEO and Founder of Median Technologies. “Lung cancer is the deadliest cancer. Being able to detect it very early is critical for patients. Our iBiopsy technology which incorporates the latest advances in Artificial Intelligence and Machine Learning could save many lives enabling the identification of lung cancers at an extremely early stage, and improving the relevance, standardization and adoption of lung cancer screening programs worldwide”.
Last September, the company reported the results of a study based on data from 1,696 patients, according to which the software, which “reads” x-rays with a precision inaccessible to the human eye, was able to characterize the pulmonary nodules with a sensitivity (ability to detect nodules) of 95.2% for a specificity (ability not to produce a false positive) of 95.7%, whereas the main reference study, the National Lung Screening Trial (NLST, at from x-rays and scanners) conducted in 2011 in the United States, produced 95% false positives.
In addition to lung cancer, Median Technologies is working on applications in liver cancer (HCC) and liver fibrosis (NASH).
Guillaume Bayre – ©2022 BFM Bourse
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