The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K260316) for Oncology Virtual Expert from Cercare Medical, a company specializing in advanced perfusion imaging solutions for neurological conditions. Oncology Virtual Expert is an AI-powered brain tumor segmentation module designed to provide fast, semi-automated tumor analysis that integrates into existing radiology workflows.

Brain tumor segmentation is typically a time-consuming step in diagnosis and treatment planning, relying on manual delineation that can vary among readers. 

The Oncology Virtual Expert module semi-automates the generation of tumor segmentation maps from standard MRI data. The platform operates on-premise, eliminating the need for cloud connectivity or external data transfer, which may help support HIPAA compliance and data governance.  

The module was validated in a cohort of approximately 100 patients and achieved a Dice coefficient of 0.82. 

“FDA clearance of Oncology Virtual Expert is a pivotal step for Cercare Medical and for neuro-oncology teams who need reliable, deployable AI tools at the point of care,” said Mikkel Bo Hansen, Chief Scientific Officer at Cercare Medical. “Our on-premise architecture was a deliberate design choice from the outset—we built this solution to integrate into the clinical environment as it exists today, without asking hospitals to change their infrastructure or compromise data security. The validation results demonstrate that we have achieved both the technical accuracy and the regulatory standard required for clinical use in the United States. We are proud to bring this capability to North American clinicians.” 

ASCO AI in Oncology is published by Conexiant under a license arrangement with the American Society of Clinical Oncology, Inc. (ASCO^®). The ideas and opinions expressed in ASCO AI in Oncology do not necessarily reflect those of Conexiant or ASCO. For more information, see Policies.