FDA Clears Cercare Medical’s AI-Powered Brain Tumor Segmentation

Cercare Medical has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Oncology Virtual Expert, an artificial intelligence (AI)-powered brain tumor segmentation module that delivers fast, consistent, semi-automated tumor analysis directly within existing clinical radiology workflows.

The clearance marks a significant milestone in Cercare Medical’s strategy to expand into the North American market, bringing advanced AI-driven segmentation to neuro-oncology teams at hospitals and academic medical centers across the United States and Canada, company executives said.

“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,” Cercare Medical Chief Scientific Officer Mikkel Bo Hansen stated. “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 on 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.”

Brain tumor segmentation is a critical step in diagnosis, treatment planning, and follow-up assessment for neuro-oncology patients. Traditionally, this process relies on manual delineation by radiologists; a time-intensive task subject to inter-reader variability. Oncology Virtual Expert semi-automates this process, generating precise tumor segmentation maps directly from standard MRI data, enabling clinicians to focus on interpretation and decision-making rather than manual contouring.

The solution operates fully on-premises, requiring no cloud connectivity or external data transfer. This architecture was designed specifically to meet the strict data governance and HIPAA compliance requirements of major U.S. health systems, including VA facilities, academic medical centers, and integrated delivery networks—where cloud-based AI solutions are often incompatible with existing IT infrastructure.

The FDA clearance is supported by clinical validation across 100 patients, demonstrating a Dice coefficient of 0.82—reflecting strong segmentation accuracy across a diverse patient population.

“North America represents a major strategic priority for us, and FDA clearance is the critical threshold for any serious clinical AI product in this market,” Cercare Medical Chief Commercial Officer Henrik Andersen commented. “We are already in active dialogue with U.S. neuro-oncology centers, radiology groups, and distribution partners who are looking for AI segmentation tools that are accurate, secure, and ready to deploy. The combination of our on-premises architecture and proven segmentation performance creates a compelling proposition for health systems that cannot or will not move patient data to the cloud.”

The Oncology Virtual Expert is built on Cercare Medical’s established neuroimaging platform, which supports advanced imaging analysis across stroke, oncology, and other neurological conditions globally. By leveraging the same underlying technology infrastructure, Cercare Medical delivers consistent, clinically validated outputs that integrate seamlessly into existing PACS and radiology workflows.

Cercare Medical provides advanced perfusion imaging solutions. With fully automated, vendor-neutral software for computed tomography, CBCT, and MRI perfusion post-processing, the company supports clinicians worldwide with tools that enhance diagnostics for stroke, oncology, Alzheimer’s disease, and neurological conditions. Cercare’s proprietary biomarkers and automated pipelines enable better imaging maps, improving speed and confidence in clinical decision-making.