FDA Expands Clearance of MRI-Guided AI Platform for Deep Brain Stimulation and Lesioning Techniques
Utilizing a new machine learning model, the OptimMRI software may improve radiosurgery applications and lesioning techniques such as MRI-guided focused ultrasound through enhanced targeting of the inferolateral part of the ventral intermediate nucleus (VIM).
The Food and Drug Administration (FDA) has granted an expanded 510(k) clearance for the artificial intelligence (AI)-powered OptimMRI software, which may bolster targeted deep brain stimulation (DBS) of neurological disorders such as essential tremor.
The expanded clearance is for the addition of a new machine learning model in the OptimMRI platform that is geared toward targeting of inferolateral part of the ventral intermediate nucleus (VIM). The improved targeting may help enhance accuracy with MRI-guided focused ultrasound (MRgFUS) lesioning techniques and radiosurgery applications, according to RebrAIn, the developer of OptimMRI.
The MRI-guided AI software OptimMRI features a newly FDA-cleared machine learning model that reportedly offers improved targeting of inferolateral part of the ventral intermediate nucleus (VIM), which may facilitate enhanced accuracy of deep brain stimulation for neurological disorders such as essential tremor. (Image courtesy of Adobe Stock.)
The company noted the OptimMRI platform previously garnered FDA clearance in January 2024 for machine learning models targeting VIM and subthalamic nucleus (STN) regions for DBS applications.
“The United States 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,” noted David Caumartin, the chief executive officer of RebrAIn.
Emmanuel Cuny, M.D., and Nejib Zemzemi, M.D., the co-founders of RebrAIn, will discuss VIM targeting during a session at the World Society for Stereotactic and Functional Neurosurgery (WSSFN) conference in Chicago on September 5. For more information, visit www.wssfn2024.org .
FDA Clears Enhanced MRI-Guided Laser Ablation System
June 5th 2025An alternative to an open neurosurgical approach, the Visualase V2 MRI-Guided Laser Ablation System reportedly utilizes laser interstitial thermal therapy (LITT) for targeted soft tissue ablation in patients with brain tumors and focal epilepsy.
Can Abbreviated MRI Have an Impact in Differentiating Intraductal Papilloma and Ductal Secretion?
June 3rd 2025For patients with inconclusive ultrasound results, abbreviated breast MRI offers comparable detection of intraductal papilloma as a full breast MRI protocol at significantly reduced times for scan acquisition and interpretation, according to a new study.
Can AI Assessment of PET Imaging Predict Treatment Outcomes for Patients with Lymphoma?
June 2nd 2025The use of adjunctive AI software with pre-treatment PET imaging demonstrated over a fourfold higher likelihood of predicting progression-free survival (PFS) in patients being treated for lymphoma, according to a new meta-analysis.
