AI-powered brain tumor segmentation tool earns clearance in US

The U.S. Food and Drug Administration has cleared a new artificial intelligence-enabled tool designed to assist with the segmentation of brain tumors. 

Denmark-basedn Cercare Medical has received 510(k) clearance for its Oncology Virtual Expert, an AI-powered brain tumor segmentation tool that can streamline and standardize neuro-oncology imaging workflows. It enables fast, consistent and semi-automated tumor delineation directly from routine MRI studies. The clearance marks a key milestone in the company’s expansion into the North American market. 

The module generates automated tumor segmentation maps from standard MRI data; this reduces reliance on manual contouring, which can be a cumbersome and time-intensive process that is vulnerable to inter-reader variability. The on-premise system can be integrated directly into existing PACS and workflows. It was designed this way so that it can operate within hospital IT constraints, such as strict HIPAA and data governance requirements that can inhibit cloud-based AI adoption in some networks. The company said the goal is to allow radiologists to focus more on interpretation and treatment planning, while reducing manual segmentation workload and improving consistency in tumor assessment. 

“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,” Mikkel Bo Hansen, chief scientific officer at Cercare Medical, said in an announcement. “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. We are proud to bring this capability to North American clinicians.” 

“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,” added Henrik Andersen, chief commercial officer at Cercare Medical. “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.” 

Read more here.