Danish neuroimaging software developer Cercare Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Oncology Virtual Expert module.
The module is designed for AI-powered brain tumor segmentation for use within existing clinical radiology workflows.
The tool semi-automates tumor segmentation from standard MRI data, generating segmentation maps without manual delineation. Clinical validation across 100 patients demonstrated a Dice coefficient of 0.82, reflecting segmentation accuracy across a diverse patient population, the company said.
The module operates fully on-premise without cloud connectivity, designed to meet HIPAA compliance and data governance requirements at U.S. health systems including VA facilities, academic medical centers, and integrated delivery networks. Cercare Medical said the FDA clearance supports the company's strategy to expand into the North American market.
