France-based precision neuro-surgery platform company RebrAIn has received expanded 510(k) approval from the US Food and Drug Administration (FDA) for its OptimMRI software.
OptimMRI is a medical software, initially approved by the US FDA in January last year, to process medical images of the brain for 3D visualisation and analysis of anatomical structures.
The new version of the software comes with an advanced machine-learning model to enable targeting the infero-lateral part of the brain’s VIM (ventralis intermedius nucleus) for lesioning techniques.
The techniques include stereotactic and functional neurosurgery for deep brain stimulation (DBS), MR-guided focused ultrasound (MRgFUS) and radiosurgery.
RebrAIn CEO David Caumartin said: “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 personalised 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.”
RebrAIn has designed the software-as-a-medical device (SaMD) by combining advanced AI algorithms, trained on clinical data, with MRI sequences.
The software solution helps neurosurgeons precisely identify the target area for surgical intervention, advancing neurosurgical target planning.
Its novel approach uses machine learning of clinical patient data to predict the optimal treatment zone in each patient’s brain.
Also, the device provides neurosurgeons with the most optimal targets for lesioning and electrode placement, said the medical device company.
