FDA Radiology AI Devices

BrainSee is software that helps clinicians predict whether patients aged 55 to 95 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer's disease dementia within 5 years. It uses standard brain MRI scans along with patient demographics and cognitive test scores to generate a similarity score indicating the likelihood of progression. This tool provides supplemental prognostic information to aid clinical decision-making but is not a standalone diagnostic device.

ClearPoint System (Software Version 2.2) is a medical software device designed to assist clinicians during neurological procedures by providing MRI-guided stereotactic guidance for the placement and operation of instruments like biopsy needles or deep brain stimulation leads. It integrates advanced automatic segmentation and visualization of brain structures from MRI scans, enhancing planning and intraoperative navigation. This helps improve surgical accuracy and patient outcomes in brain interventions.