Already FDA 510(k) cleared in 2024, OptimMRI is an AI-powered surgical planning platform that supports Deep Brain Stimulation (DBS) and lesioning procedures (HIFU & Radiosurgery) targeting the STN and VIM regions. With MDR certification now secured, RebrAIn is authorized to fully commercialize its solution across both European and U.S. markets for patients with movement disorders such as Parkinson’s disease and essential tremor.
This certification further enables RebrAIn to support neurosurgical teams working with leading technologies from companies such as Insightec, Elekta, Accuray, and Varian/Siemens.
“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,” said David Caumartin, CEO of RebrAIn.
By transforming medical imaging into actionable 3D brain models powered by AI and trained on real-world outcomes, OptimMRI empowers surgical teams with smarter, data-driven tools for high-precision planning. This new certification marks a crucial step forward (crucial step ou step forward) in RebrAIn’s mission to advance personalized neurosurgery and improve clinical outcomes worldwide.
