Rebrain has announced CE certification under the European Medical Device Regulation (MDR) of its OptimMRI solution. This certification covers both the quality management system (QMS) and product certification for OptimMRI, according to a company press release.
OptimMRI is a software solution supporting deep brain stimulation (DBS) and lesioning (high-intensity focused ultrasound [HIFU] and radiosurgery) procedures targeting the subthalamic nucleus (STN) and ventralis intermedius nucleus (VIM).
With the technology having received US Food and Drug Administration (FDA) 510(k) clearance in 2024, Rebrain notes that the recent CE marking represents a “significant validation” of its strategic commitment to delivering the highest quality standards for precise and personalised neurosurgical treatment plans.
The company’s full suite of services is now authorised for commercialisation across European markets, adding lesioning to the already-cleared DBS techniques for treating patients with Parkinson’s disease and essential tremor.
“Securing MDR certification is a major milestone that reflects the maturity of our organisation and our unwavering commitment to excellence,” said David Caumartin, chief executive officer (CEO) of Rebrain. “It enables us to offer our precision AI [artificial intelligence]-powered neuromodulation planning services across Europe, helping neurosurgeons deliver safer, faster and more personalised treatments to patients affected by debilitating movement disorders.”
