RebrAIn, a leading medtech company based in Bordeaux, France, with operations in Europe and the United States, has secured CE certification under the European Medical Device Regulation (MDR 2017/745). This certification encompasses both the Quality Management System (QMS) and product certification for RebrAIn's OptimMRI software, a significant achievement that underscores the company’s dedication to high-quality, precise, and personalized neurosurgical treatment plans. RebrAIn's OptimMRI is a software solution designed to support Deep Brain Stimulation (DBS) and lesioning procedures, such as High-Intensity Focused Ultrasound (HIFU) and Radiosurgery, targeting the Subthalamic Nucleus (STN) and Ventral Intermediate Nucleus (VIM). The software had already received FDA 510(k) clearance in 2024 for its DBS capabilities. With the new CE marking under the MDR, OptimMRI is now approved for commercialization across European markets, expanding its scope to include lesioning techniques, which are critical for treating conditions like Parkinson’s Disease and essential tremor. RebrAIn’s OptimMRI platform enhances the precision of neurosurgical planning by leveraging advanced imaging and machine learning algorithms. It allows surgical teams to accurately identify and target specific areas of the brain, ensuring safer, more efficient, and highly personalized procedures. The software processes pre-operative MRI images to create detailed 3D models of the brain, annotated with key regions of interest. These models can be integrated with other clinical methods to optimize the localization of the STN and VIM, making the surgical planning process more accurate and reliable. David Caumartin, CEO of RebrAIn, expressed his enthusiasm about this milestone: "Securing MDR certification is a significant step forward for RebrAIn. It reflects the maturity and robustness of our organization and our unwavering commitment to excellence. With this certification, we can now bring our cutting-edge, AI-powered neuromodulation planning services to the European market, enabling neurosurgeons to deliver safer, faster, and more tailored treatments to patients suffering from debilitating movement disorders." The MDR certification not only validates RebrAIn’s adherence to stringent quality standards but also positions the company as a trusted partner for healthcare institutions looking to adopt precision neurosurgery technologies. European healthcare providers will now have access to RebrAIn’s clinically validated, AI-driven tools, which can significantly improve the efficiency and accuracy of DBS and lesioning interventions. About RebrAIn RebrAIn is a French company that specializes in developing technology to enhance the precision of DBS and lesioning treatments for patients with severe Parkinson’s Disease and essential tremor. Its software-as-a-service (SaaS) solution, OptimMRI, aids neurosurgeons in identifying the exact target areas for surgical interventions. By using machine learning to analyze clinical patient outcomes, RebrAIn predicts the optimal treatment zones within each patient’s brain, thereby increasing the likelihood of successful outcomes. About OptimMRI OptimMRI is a specialized software application that assists medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. It processes pre-operative DICOM-compatible MRI images to generate 3D annotated models of the brain, which help in neurosurgical functional planning. These models can be used alongside other clinical techniques to pinpoint the locations of the STN and VIM regions, critical targets for DBS and lesioning procedures. Meta Description: RebrAIn secures MDR certification for its OptimMRI software, advancing its mission to deliver precision AI-powered neuromodulation targeting for DBS and lesioning treatments across European markets. 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