FDA Radiology AI Devices

The Nurochek-Pro System is a portable EEG-based device that generates visual evoked potentials to help healthcare professionals diagnose mild traumatic brain injury (mTBI) in patients aged 12 to 44. Worn on the patient's head, it records brain electrical activity and provides an analytic aid to detect mTBI within 5 days after a potential head injury, improving diagnostic accuracy in clinical settings.

BrainScope TBI is a portable, non-invasive device that assists clinicians in evaluating patients with mild traumatic brain injury and concussion by analyzing brain electrical activity through EEG along with cognitive tests and clinical symptoms. It helps identify the likelihood of structural brain injury and assesses brain function, supporting decisions about the need for further imaging like CT scans.

The Ahead 300 is a portable, non-invasive medical device that records and analyzes brain electrical activity to assist clinicians in evaluating patients with closed head injuries. It provides algorithm-based classifications of structural brain injury and measures brain function and cognitive performance to support diagnosis and treatment decisions, particularly to aid in deciding on the necessity of head CT scans.

The BrainScope Ahead 200 is a portable EEG device designed to aid physicians in evaluating patients with mild traumatic brain injury by measuring and analyzing brain electrical activity. It supports clinical decision-making regarding the need for head CT scans by providing objective quantitative EEG parameters. The device is intended for use as an adjunct to standard clinical practice and includes features such as continuous impedance monitoring and cognitive assessment tools for military use. It helps clinicians by providing rapid brain activity data to support the assessment of brain injury severity without replacing imaging such as CT scans.