RebrAIn has gained its second U.S. Food and Drug Administration (FDA) 510(k) clearance for its OptimMRI software, which now includes a new machine learning model to assist in targeting the infero-lateral part of the ventralis intermedius nucleus (VIM) for lesioning techniques such as MRgFUS and radiosurgery. This new software version already features FDA-cleared machine learning models for the STN and VIM regions of interest to assist in targeting deep brain stimulation (DBS).
 
This clearance is RebrAIn’s second in the past year, and expands the software’s capabilities to include the infero-lateral part of the VIM. RebrAIn’s software as a medical device (SaMD) is designed to revolutionize neurosurgical target planning by combining advanced AI algorithms, trained on clinical data, with MRI sequences to provide neurosurgeons with the most optimal targets for lesioning and electrode placement.
 
“Our extension to US customers to better plan targets for lesioning is a significant step in RebrAIn’s growth and strategic transformation,” RebrAIn CEO David Caumartin stated. “The U.S. market represents the largest opportunity to enable personalized targeting for neurological disorders such as Essential Tremor. The ability to offer AI clinical targeting to neurosurgical suites will open many collaborations nationwide, which today are treated with DBS and MR-guided focused ultrasound. Since our recent discussions at U.S. congresses, it was necessary for us to offer neurosurgeons a complete service.”
   
RebrAIn is a France-based company that enables 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 approach uses machine learning of clinical patient data to predict the optimal treatment zone in each patient’s brain.