RebrAIn Secures Second FDA Clearance for Enhancing Targeting in Neurosurgery

RebrAIn, a leader in precision neuro-surgery platforms, has secured its second FDA 510(k) clearance for its OptimMRI software. The latest version includes a machine learning model designed to aid in targeting the infero-lateral part of the VIM for lesioning techniques like MR-guided focused ultrasound (MRgFUS) and Radiosurgery. This update adds to the software’s existing FDA-cleared models for the STN and VIM regions, which assist in targeting for Deep Brain Stimulation (DBS).

RebrAIn has received its second FDA 510(k) clearance within a year, enhancing its software’s capabilities to target the infero-lateral part of the VIM. The company’s software as a medical device (SaMD) utilizes advanced AI algorithms trained on clinical data, paired with MRI sequences, to optimize neurosurgical target planning for lesioning and electrode placement.

David Caumartin, CEO of RebrAIn, commented, “Expanding our offering to U.S. customers for better lesioning target planning marks a significant milestone in RebrAIn’s strategic growth. The U.S. market is the largest opportunity for personalized targeting in neurological disorders like Essential Tremor. By bringing AI-driven clinical targeting to neurosurgical suites, we anticipate numerous national collaborations, particularly in DBS and MR-guided focused ultrasound treatments.”

RebrAIn co-founders Prof. Emmanuel Cuny, MD, and Prof. Nejib Zemzemi, PhD, will present 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.

About RebrAIn

RebrAIn is a France-based company specializing in precise targeting solutions for DBS and lesioning treatments for patients with severe Parkinson’s or essential tremor. Its SaaS platform assists neurosurgeons in accurately identifying target areas for surgical interventions, using machine learning models trained on clinical data to predict optimal treatment zones in the brain. For more information, visit www.rebrain.eu.

About the World Society for Stereotactic and Functional Neurosurgery

Established in 1961, the WSSFN is a leading neurosurgery conference where experts present the latest innovations in clinical and basic research, along with new approaches to neurosurgical practice and support.

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