RebrAIn, a pioneering precision neuro-surgery platform company, has recently received its second 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 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).
RebrAIn has secured its second FDA 510(k) clearance in the past year, expanding 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.
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David Caumartin, CEO of RebrAIn, stated, “Our extension to US customers to better plan targets for lesioning is a significant step in RebrAIn’s growth and strategic transformation. The US 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 US congresses, it was necessary for us to offer neurosurgeons a complete service.”
RebrAIn’s co-founders, Prof. Emmanuel Cuny MD and Prof. Nejib Zemzemi PhD, will be presenting on “VIM Lesions in Radiosurgery and Focused Ultrasound: Assessment of the Accuracy of Two Targeting Models Based on Machine Learning” at the World Society for Stereotactic and Functional Neurosurgery (WSSFN) biennial meeting in Chicago, IL, on September 5, 2024.
“Our extension to US customers to better plan targets for lesioning is a significant step in RebrAIn’s growth and strategic transformation,” said David Caumartin, CEO of RebrAIn. “The US market is the largest, and the ability to offer AI clinical targeting will open many national collaborations.”
Source: Businesswire