RebrAIn Receives Second FDA 510(k) Clearance to Optimize Targeting in Stereotactic and Functional Neurosurgery for Both Deep Brain Stimulation and Lesioning Techniques (MRgFUS and Radiosurgery)

Co-Founders Presenting VIM Targeting at the WSSFN (World Society for Stereotactic and Functional Neurosurgery) Congress

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.

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.”

To learn more, visit us at Booth #9 during the WSSFN meeting,

check out our website www.rebrain.eu, or contact us directly.

About RebrAIn

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 novel approach uses machine learning of clinical patient data to predict the optimal treatment zone in each patient’s brain. For more information, visit www.rebrain.eu.

About the World Society for Stereotactic and Functional Neurosurgery

Since 1961, the WSSFN has been regularly held and continues to be a leading neurosurgery conference.

At the biennial meetings, the top leaders in the field present the most recent innovations in clinical and basic research as well as new and effective ways to provide material support.

Meta Description: "RebrAIn receives its second FDA 510(k) clearance for OptimMRI software, enhancing targeting in stereotactic and functional neurosurgery for Deep Brain Stimulation and lesioning techniques. The company will present VIM targeting advancements at the WSSFN congress."

Tags: FDA 510(k) Clearance, Deep Brain Stimulation (DBS), Stereotactic Neurosurgery, Functional Neurosurgery, Medical Device Software, Machine Learning in Healthcare, MR-guided Focused Ultrasound (MRgFUS), Radiosurgery, Neurotechnology, WSSFN Congress, RebrAIn, Essential Tremor Treatment, AI in Healthcare, Precision Neurosurgery, Healthcare Innovations.

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