RebrAIn has gained CE Mark approval for its OptimMRI software solution. Supporting deep brain stimulation (DBS) and lesioning (HIFU and radiosurgery) procedures targeting the subthalamic nucleus (STN) and ventral intermediate nucleus (VIM), OptimMRI received U.S. Food and Drug Administration 510(k) clearance last year.

The CE marking under Europe’s Medical Device Regulation represents a significant validation of RebrAIn’s strategic commitment to delivering high quality standards for precise and personalized neurosurgical treatment plans. RebrAIn’s full suite of services is now authorized for commercialization across European markets adding lesioning to the previously cleared DBS techniques to treat patients with Parkinson’s Disease and essential tremor.

RebrAIn’s OptimMRI platform enables surgical teams to enhance neurosurgical planning precision, particularly in neurosurgery suites offering lesioning methods provided by available technologies. The software application aims to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible magnetic resonance (MR) images to generate 3D annotated models of the brain that help userd with neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localizing STN and VIM regions of interest.

“Securing MDR certification is a major milestone that reflects the maturity of our organization and our commitment to excellence,” RebrAIn CEO David Caumartin said. “It enables us to offer our precision AI-powered neuromodulation planning services across Europe, helping neurosurgeons deliver safer, faster, and more personalized treatments to patients affected by debilitating movement disorders.”

RebrAIn is a French-based company that provides technology to enable precise targeting for DBS and lesioning treatments for patients suffering from severe Parkinson’s or essential tremor disease. Its SaaS solution helps neurosurgeons precisely identify the target area for surgical intervention. Its approach uses machine learning of clinical patient outcomes to predict optimal treatment zone in each patient’s brain.