The median iBiopsy® LCS has received a response from the FDA regarding 513 (g) filing for CADe / CADx medical device software.
Median will file a 510 (k) filing for FDA marketing clearance for its medical device software, scheduled for the end of 2023.
On May 2, Media began a preliminary submission (Q-submission) process to obtain the FDA’s opinion on a number of elements, including the protocol for the initial study.
Sophia Antipolis, France – (Business Wire) – Regulatory News:
Media Technologies (ALMDT) announced today that it has received feedback from the Food and Drug Administration (FDA) regarding the 513 (g) filing for iBiopsy® Lung Cancer Screening (LCS) CADe / CADx medical device software.1 Based on artificial intelligence and machine learning technology.
The purpose of filing 513 (g) was to identify the appropriate product classification and choose the best regulatory path between submitting a De Novo type and submitting a 510 (k) type.2, iBiopsy® LCS for CADe / CADx Medical Device Software. The FDA has determined that Median’s iBiopsy® LCS CADe / CADx medical device software falls under 21 CFR 892.2090 (Radiological Computer Assisted Detection and Diagnosis Software), a Class II device to be submitted, for which marketing is available. Approval from the FDA.
Subsequent regulatory measures for median technology consist of the preparation of several initial “queue-deposits” between the second and third quarters of 2022. Median, for example, began the process on May 2 and sent its first Q-submission to the FDA, specifically focusing on a review of key study protocols and potential predictions. A meeting with FDA experts will be scheduled soon depending on their availability.
” Following this response from the FDA in our 513 (g) file, we wish to maintain frequent and fruitful interaction with the agency to better adapt our device to the American market. “Frederick Bragg is the CEO and founder of Median Technologies “The design of our main study will be a key element in demonstrating the unique effectiveness of our iBiopsy® LCS CADe / CADx medical device software and how it can save patients from being diagnosed with lung cancer as early as possible.”
About iBiopsy® : iBiopsy করে Integrates the most advanced technologies in artificial intelligence and data science and relies on the expertise of median technology in the processing of medical images. iBiopsy® is an indication of the development of AI-based medical device software for indications that there is an unmet need for early diagnosis, prognosis and treatment selection in terms of predictive and precise medication. iBiopsy® currently focuses on Lung Cancer, Liver Cancer (HCC) and Liver Fibrosis (NASH).
About Media Technology: Median Technologies provides innovative software solutions and imaging services to advance healthcare for all. We harness the power of the medical picture using the most advanced artificial intelligence technology to enhance the accuracy of diagnosis and treatment of many cancers and metabolic diseases and to contribute to the emergence of new therapies for patients. Our iCRO solution for analyzing and managing medical images in Oncology Clinical Trials and iBiopsy®, as a medical device based on AI technology, our software helps biopharmaceutical companies and physicians to bring new treatments to patients and diagnose previous and more accurate diseases. . In this way, we contribute to a healthier world.
Created in 2002, with a subsidiary in the United States in Sophia Antipolis, France, and another in Shanghai, Median has been labeled an “innovative company” by BPI Finance and listed on the Euronext Growth Market (Paris) -ISIN code: FR0011049824: . Eligible for the Median PEA PME, Enternext® appears on the PEA-PME 150 Index and is labeled European Rising Tech by Euronext. More information at www.mediantechnologies.com
1 A radiological CADe device is “for the purpose of identifying, identifying, highlighting, or drawing attention to areas of interest in an image that may reveal abnormalities after being explained by a physician.” A CADx device “intended to provide information beyond the detection of abnormalities, such as disease assessment” (FDA source translation).
2 510 (k) and De Novo are the only two possible regulatory pathways that could introduce a low to medium risk medical device into the US market. Unlike the traditional 510 (k), the ‘De Novo’ classification is based on a risk assessment process and is approved for devices that do not meet the 510 (k) submission criteria. Source: FDA
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