FDA Radiology AI Devices

The Atlas Stim Headbox by Neuralynx, Inc. is a medical device intended for cortical or intracranial stimulation during EEG examinations, such as stereo EEG (SEEG). It works as an accessory to the ATLAS Neurophysiology System, enabling controlled electrical stimulation of the brain using third-party electrodes and recording the brain's electrical responses. This device assists neurosurgeons and neurologists in mapping brain function, especially in complex cases requiring precise neural stimulation.

NEAT 001 is a software medical device that automatically analyzes EEG data obtained during sleep studies to detect different stages of sleep according to established sleep medicine guidelines. It helps clinicians by providing automated scoring and visualization of sleep stages, improving the efficiency and consistency of sleep evaluations in adult patients.

autoSCORE V2.0 is an AI-based software that helps medical professionals review EEG recordings by identifying and classifying sections indicating brain abnormalities such as epileptiform and non-epileptiform activities. It assists neurologists by marking likely abnormal EEG segments, providing probabilities for specific abnormality types, thereby enhancing the efficiency and accuracy of EEG interpretation without replacing clinical judgment.

The EyeBOX EBX-4.1 is an eye-tracking device designed to help diagnose concussions by measuring eye movements. It uses a high-speed infrared camera to record gaze while the patient watches a video stimulus. The device automatically analyzes the data and produces a BOX score indicating the likelihood of concussion, comparing the eye tracking metrics to a normative database of uninjured individuals. This helps clinicians assess brain injury more objectively and quickly.

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.

DeepRESP is a cloud-based AI software tool that analyzes sleep study recordings, with or without EEG signals, to assist clinicians in diagnosing sleep disorders. It automatically marks events, calculates parameters like the Apnea-Hypopnea Index, and infers sleep stages. This helps medical professionals to efficiently assess sleep health and tailor treatments.

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are medical devices designed to assist in the revascularization of patients experiencing acute ischemic stroke caused by large vessel occlusions in the brain. The catheter is used alongside a compatible aspiration pump to remove blood clots from the affected neurovasculature, helping to restore blood flow. This device is intended for use within 8 hours of stroke symptom onset and for patients who have not responded to or are ineligible for thrombolytic drug therapy.

The Penumbra System (Reperfusion Catheter RED 72) is a catheter-based device designed to remove blood clots in the brain's large vessels to treat acute ischemic stroke. It uses aspiration to restore blood flow in blocked intracranial vessels during neurointerventional procedures, guided by fluoroscopy. This device helps clinicians revascularize patients who are ineligible or have failed thrombolytic drug therapy, improving stroke treatment outcomes.

The Navient Image Guide Navigation System is a computerized surgical navigation system designed to assist surgeons in precisely locating anatomical structures during neurosurgical procedures. It helps surgeons plan and navigate in real time using CT or MR images, improving accuracy and safety in cranial operations such as tumor resection and biopsies.

The Alignment System Cranial by Brainlab AG is an image guided surgical system designed to assist neurosurgeons in planning and precisely guiding surgical instruments during cranial stereotactic procedures such as biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and laser interstitial thermal therapy (LITT). It uses optical tracking technology and specialized software to continuously track instrument positions relative to patient anatomy on pre- or intraoperative images, helping clinicians achieve accurate trajectories to improve procedural safety and effectiveness.