FDA Clears Emerging AI Segmentation Module for Brain MRI
The Oncology Virtual Expert AI software reportedly provides semi-automated segmentation maps of brain tumors based on standard brain MRI scans.
The Food and Drug Administration (FDA) has granted 510(k) clearance for Oncology Virtual Expert, an AI-powered MRI software that provides semi-automated segmentation of brain tumors.
Cercare Medical, the developer of
The software provides a viable alternative to time-consuming manual contouring of tumor segmentation with brain MRI that can be subject to inter-reader variability, according to Cercare Medical.
The company also emphasized that the on-premise nature of the Oncology Virtual Expert software facilitates use in large health-care systems in the United States that have strict requirements for data governance and HIPAA compliance.
“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, the 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.”
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