MDR Approval Marks Major Milestone for RebrAIn’s OptimMRI Platform in Europe

RebrAIn, a pioneering France based medtech company, with commercial operations in Europe and the United States, today proudly announced the achievement of its CE certification under the new European Medical Device Regulation (MDR 2017/745). This certification covers both the Quality Management System (QMS) and product certification for RebrAIn’s OptimMRI.

OptimMRI, RebrAIn’s software solution supporting Deep Brain Stimulation (DBS) and lesioning (HIFU and Radiosurgery) procedures targeting the STN and VIM, had previously received FDA 510(k) clearance in 2024. The recent CE marking under the MDR represents a significant validation of RebrAIn’s strategic commitment to delivering the highest 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 already cleared DBS techniques to treat patients with Parkinson’s Disease and essential tremor.

RebrAIn’s OptimMRI platform enables surgical teams to enhance the precision of neurosurgical planning, particularly in neurosurgery suites offering lesioning methods provided by leading technologies available on the market.

David Caumartin, CEO of RebrAIn, commented:

"Securing MDR certification is a major milestone that reflects the maturity of our organization and our unwavering commitment to excellence. 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."

The MDR certification is a critical step that strengthens RebrAIn’s positioning as a trusted partner for institutions, thanks to OptimMRI, embracing the future of precision neurosurgery. It ensures that European healthcare providers can now access RebrAIn’s clinically validated, AI-driven technologies for optimized targeting in DBS and lesioning interventions.

About RebrAIn

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 to precisely identify the target area for surgical intervention. Its novel approach uses machine learning of clinical patient outcomes to predict optimal treatment zone in each patient’s brain. For more information, visit www.rebrain.eu.

About OptimMRI

OptimMRI is a software application intended 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 MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.

Meta Description: "RebrAIn achieves MDR certification with DQS for its OptimMRI software, reinforcing its strategic commitment to delivering precision AI-powered neuromodulation targeting for Deep Brain Stimulation and lesioning treatments across Europe."

Tags: MDR Certification, Medical Devices, DBS, Lesioning Techniques, Precision Neurosurgery, AI in Healthcare, Machine Learning in Medicine, Neuromodulation, RebrAIn, Healthcare Innovation, Movement Disorders, Deep Brain Stimulation, Medical Device Regulation, Neurosurgery, European Healthcare Market

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