FDA Approves Rebrain’s AI Software for Precision Brain Targeting

Rebrain’s OptimMRI software, now featuring a new machine learning model, has been cleared by the U.S. Food and Drug Administration (FDA) to assist in targeting brain regions for lesioning techniques. These techniques, such as MR-guided focused ultrasound and radiosurgery, involve the destruction of small areas of abnormal brain activity and are used in treating neurological conditions.

Lesioning Techniques and Deep Brain Stimulation (DBS)

Lesioning techniques are designed to destroy targeted areas of abnormal brain activity, helping ease motor symptoms of conditions like Parkinson’s disease. OptimMRI’s newly approved AI model aids in the precise targeting of brain regions, enhancing techniques like deep brain stimulation (DBS) and lesioning.

DBS, which involves implanting electrodes to stimulate brain regions with electrical impulses, is often used when medications fail to manage symptoms like tremors, muscle rigidity, and slowed movements in Parkinson’s patients. Both lesioning and DBS are used to improve motor symptoms and quality of life.

Combining AI and MRI for Better Precision

OptimMRI leverages artificial intelligence in combination with MRI to accurately identify optimal brain targets for electrode placement or lesioning. This is crucial for neurosurgeons, who rely on precision when planning procedures.

Rebrain submitted its software for approval through a 510(k) application, a process used to gain FDA clearance for medical devices in the U.S.

Expanding AI Technology to More Brain Regions

The first version of OptimMRI, already cleared by the FDA, focused on targeting the subthalamic nucleus, a key region involved in movement coordination and a common DBS target in Parkinson’s patients. The latest version expands its capabilities to include the ventralis intermedius nucleus (VIM), a brain region involved in sensory-motor integration, commonly targeted for essential tremor treatment.

Streamlining Neurosurgical Procedures

Rebrain’s technology simplifies the process of identifying brain structures using AI, which predicts and marks the optimal targets on MRI scans. These AI-generated predictions are then verified by neurosurgeons before being used to plan surgeries.

Rebrain aims to standardize neurosurgical procedures globally, ensuring more patients can receive life-changing treatments. “The U.S. market represents the largest opportunity to enable personalized targeting for neurological disorders,” said David Caumartin, CEO of Rebrain, in a press release. He added that offering AI-based clinical targeting in neurosurgical suites will facilitate more collaborations across the country.

Presenting New Data at International Conference

Rebrain’s co-founders, Emmanuel Cuny, MD, and Nejib Zemzemi, PhD, are set to present their latest findings on machine learning-based VIM targeting at the World Society for Stereotactic and Functional Neurosurgery, taking place in Chicago on September 5.