AARHUS, DENMARK, 25 June 2026: Cercare Medical, a leader in advanced neuroimaging software, today announced FDA 510(k) clearance (K260316) for its Oncology Virtual Expert, an AI-powered brain tumor segmentation module designed to deliver fast, consistent, and 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.
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-premise, 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.
“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 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.”
Henrik Andersen, Chief Commercial Officer at Cercare Medical, added: “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. 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-premise 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 Receives FDA 510(k) Clearance for Cone-Beam CT Perfusion
>>> Siemens Healthineers and Cercare Medical Announce Global Collaboration on Cone-Beam CT Perfusion Guided Stroke Treatment
>>> Cercare Medical Releases Version 18 of Neurosuite: Advancing Stroke and Oncology Workflows
>>> Cercare Medical Showcases Breakthrough CBCT Perfusion Technology at RSNA 2025
About Cercare Medical
Cercare Medical is a provider of advanced perfusion imaging solutions. With fully automated, vendor-neutral software for CT, CBCT, and MRI perfusion post-processing, the company supports clinicians across the world 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.
