FDA Radiology AI Devices

The Affirm 800 is a surgical imaging device that helps neurosurgeons visualize blood flow and vessel patency in the brain during operations. It works by using near-infrared light to activate a fluorescent dye (Indocyanine Green) injected into the bloodstream, allowing surgeons to see detailed images of cerebral vessels on a 3D monitor in real time. This aids in assessing occlusions and blood flow in vessels, improving surgical outcomes.

The Neuralytix iD3 System is a surgical nerve stimulator and locator that helps surgeons find and monitor motor nerves during surgery by measuring muscle responses to electrical stimulation. It uses mechanomyographic signals to assess nerve function in real-time, enabling safer and more effective surgical interventions involving nerve mapping and monitoring.

The Visualase V2 MRI-Guided Laser Ablation System is a neurosurgical tool designed to ablate, necrotize, or coagulate brain tissue including tumors and epileptic foci, using a laser controlled and monitored in real-time via MRI thermometry. It helps clinicians precisely target and treat affected brain areas in adults and pediatric patients aged 2 years and older.

The Zoom 7X Catheter, along with the Zoom Aspiration Tubing and Zoom POD Aspiration Tubing, is a sterile, single-use medical device designed to remove blood clots from large intracranial vessels in patients experiencing an acute ischemic stroke. It helps restore blood flow by aspirating the clot when connected to an aspiration pump, aiding clinicians in rapidly treating stroke and improving patient outcomes.

NeuroMatch is a cloud-based software that assists neurologists by reviewing and analyzing EEG recordings to detect seizures and spikes, reduce artifacts, and visualize brain electrical activity through 3D source localization on an idealized head model. It helps clinicians understand brain activity over time by displaying quantitative trends, improving EEG assessment without providing diagnostic conclusions.

The Stereotaxic Guiding Surgical Device, NaoTrac S, is a robotic system designed to assist neurosurgeons in accurately positioning and guiding surgical instruments during stereotactic neurosurgical procedures. By using preoperative MRI or CT images for planning and intraoperative guidance, it helps surgeons precisely target brain regions for biopsies, electrode placement, or other interventions, improving surgical accuracy and patient safety.

The HJY VisualNext 3D Endoscopic Vision System is a medical device designed to provide surgeons with a 3D visual of internal surgical sites during neurological, spinal, and general surgeries. It uses dual CMOS sensors and integrated LED lighting to capture and display high-resolution 3D images on an external monitor, helping clinicians better visualize the surgical area for improved precision and outcomes.

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a device used to remove blood clots in patients suffering from acute ischemic stroke caused by large vessel blockages in the brain. It is used with a compatible vacuum pump to restore blood flow within 8 hours of stroke onset, helping patients who are not eligible for or have failed drug therapy. This system comprises catheters and tubing designed for safe and effective clot removal in neurovascular procedures.

ANKYRAS is a medical software device designed to assist clinicians in visualizing cerebral blood vessels and simulating the placement and sizing of neurointerventional braided endovascular devices such as flow diverters. It helps physicians plan neurovascular interventions by allowing 3D modeling based on imaging data from 3D rotational angiography, offering features like segmentation, centerline generation, and device simulation to improve pre-surgical planning and patient outcomes.

The Neu Platform is a smartphone application and clinician dashboard system designed to remotely measure and quantify tremor severity in patients aged 45 or older with mild to moderate Parkinson's Disease. It collects motion data via smartphone accelerometers, allowing patients to perform motor assessments and report symptoms remotely, while clinicians can review this data in a secure web portal to monitor and manage the patient's condition more effectively.