RebrAIn, a pioneering France based medtech company, with commercial operations in Europe and the United States, 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.
Related: VUNO’s cardiac arrest risk monitoring system gains EU and UK certification
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.
