Median Technologies has filed a 513(g) submission with the US Food and Drug Administration (FDA) seeking regulatory approval for its iBiopsy lung cancer screening (LCS) solution.
The iBiopsy is an end-to-end CADe/CADx1 Software as Medical Device (SaMD), developed based on advanced AI/ML technologies, to facilitate lung cancer screening.
With the 513(g) submission, the company is enabled to select between ‘De Novo’ or the 510(k) regulatory pathways and determine suitable product classification for the LCS solution.
The US agency is expected to review the company’s 513(g) submission and provide feedback within 60 days from the submission.
Median Technologies CEO and founder Fredrik Brag said: “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.
“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.”
Median Technologies has developed iBiopsy using advanced technologies in artificial intelligence (AI), data science, and its expertise in medical image processing.
In September last year, the company announced that iBiopsy has shown superior results in characterising malignant and benign lung nodules in lung cancer screening.
The solution currently focuses on lung cancer, liver cancer (HCC) and liver fibrosis (NASH).
The company intends to expand its use in several indications that address unmet needs in early diagnosis, prognosis and treatment selection in precision medicine.
Median Technologies is engaged in providing advanced imaging solutions and services, using advanced Artificial Intelligence technologies.
It offers enhanced accuracy in the early diagnosis and treatment of cancers and other metabolic diseases, and provide insights into novel therapies for patients.
The company offers iCRO solutions for medical image analysis and management in oncology trials and iBiopsy as a medical device for early diagnosis and treatment.
