Median Technologies iBiopsy Lung Cancer Screening Software
pharmafile | March 4, 2022 | News story | Medical Communications |
Median Technologies has announced that the company has filed a regulatory submission to the FDA for its iBiopsy Lung Cancer Screening (LCS) technology-based end-to-end Software as Medical Device (SaMD).
The 513(g) submission will allow Median Technologies to determine the best product classification and choose between regulatory pathways for iBiopsy® LCS CADe/CADx SaMD. The FDA is expected to review the 513(g) submission and provide feedback within 60 calendar days.
The company has shared that it aims to obtain a full device approval and market authorisation by the end of 2023, and proceed with subsequent commercialisation of the software. As next regulatory steps, Median Technologies is preparing several Q-submissions for Q2, 2022.
It is hoped that iBiopsy will significantly contribute to eliminating barriers to the widespread adoption of lung cancer screening programs and save the lives of millions of patients through early diagnosis and subsequent early treatment.
“This first regulatory submission marks the beginning of our interactions with the FDA. The FDA’s feedback will help us determine the shortest and most efficient way to bring our product onto the US healthcare market”, Fredrik Brag, CEO and founder of Median Technologies said. “Lung cancer is the deadliest cancer, and being able to detect it very early is of critical importance for patients. Our innovative iBiopsy AI/ML-based technology could have a huge impact on saving patients’ lives by identifying lung cancer onsets at their earliest stage, and could significantly improve the accuracy, consistency, and adoption of lung cancer screening programs worldwide”.
iBiopsy is based on the most advanced technologies in Artificial Intelligence (AI) and Data Science (DS), drawing from Median’s expertise in medical image processing, to be used in several indications for which there are unmet needs regarding early diagnosis, prognosis and treatment selection in the context of precision medicine. iBiopsy currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).
Ana Ovey
