Median has received the response from the FDA regarding its 513(g) filing for iBiopsy® LCS CADe/CADx medical device software.
Median will file a 510(k) filing for FDA marketing clearance for its medical device software, scheduled for late 2023.
On May 2, Median initiated a process of preliminary submissions (Q-submission), in order to obtain the opinion of the FDA on several elements, including the protocols for the pivotal studies.
SOPHIA ANTIPOLIS, France–(BUSINESS WIRE)–Regulatory News:
Median Technologies (ALMDT) announces today that it has received the response from the Food and Drug Administration (FDA) regarding its 513(g) filing for the iBiopsy® Lung Cancer Screening (LCS) CADe/CADx medical device software1 based on Artificial Intelligence and Machine Learning technologies.
The purpose of filing the 513(g) filing was to identify the appropriate product classification and choose the best regulatory path between a De Novo type submission and a 510(k) type submission.2, for iBiopsy® LCS 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, which requires the submission of a 510(k). ) to obtain marketing authorization from the FDA.
The next regulatory steps for Median Technologies consist of the preparation, during the second and third quarters of 2022, of several preliminary “Q-submissions”. As such, Median initiated the process on May 2 and sent the FDA its first Q-submission which specifically focuses on the review of pivotal study protocols and potential predicates. A meeting with FDA experts will be scheduled shortly depending on their availability.
” After this response from the FDA on our 513(g) file, our wish is to maintain frequent and fruitful interactions with the Agency in order to better adjust our device to the American market. “says Fredrik Brag, CEO and founder of Median Technologies. “The design of our pivotal studies will be a key element in showing the unique performance of our iBiopsy® LCS CADe/CADx medical device software and how it could save patients by diagnosing lung cancer as early as possible”.
About iBiopsy® : iBiopsy® integrates the most advanced technologies of Artificial Intelligence and data science and relies on the expertise of Median Technologies in the processing of medical images. iBiopsy® targets the development of AI-based medical device software for indications for which unmet medical needs exist in terms of early diagnosis, prognosis and treatment selection in the context of predictive and precision medicine. iBiopsy® currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).
About Median Technologies: Median Technologies provides innovative software solutions and imaging services to advance healthcare for all. We harness the power of medical images using the most advanced artificial intelligence technologies to increase accuracy in the diagnosis and treatment of many cancers and metabolic diseases and contribute to the emergence of new therapies for patients. Our iCRO solutions for the analysis and management of medical images in oncology clinical trials and iBiopsy®, our software as a medical device based on AI technologies help biopharmaceutical companies and clinicians bring new treatments to patients and earlier and more accurate diagnoses. In this way, we contribute to a healthier world.
Created in 2002, based in Sophia Antipolis in France with a subsidiary in the United States and another in Shanghai, Median is labeled “Innovative Company” by BPI Financement and is listed on the Euronext Growth market (Paris) -ISIN code: FR0011049824– MNEMO code: ALMDT. Median is eligible for the PEA PME, appears in the Enternext® PEA-PME 150 index and is labeled European Rising Tech by Euronext. More information on www.mediantechnologies.com
1 A radiological CADe device is “intended to identify, mark, highlight, or draw attention to areas of interest in an image that may reveal abnormalities when interpreted by the clinician”. A CADx device is “intended to provide information beyond the identification of abnormalities, such as an assessment of disease” (FDA source translation).
2 510(k) and De Novo are the only two possible regulatory pathways to submit a low-to-moderate risk medical device to the US market. In comparison to traditional 510(k), ‘De Novo’ classification is based on a risk determination process and is permitted for devices that have not met the 510(k) submission criteria. Source: FDA
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