FDA Radiology AI Devices

Methinks CTA Stroke is an AI software tool designed to assist clinicians by automatically analyzing CT angiography images of the brain to detect signs of stroke. It helps prioritize urgent cases by providing triage and notification, enabling faster diagnosis and treatment for patients.

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.

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 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.

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.

Brainomix 360 e-ASPECTS is an AI-based software that analyzes non-contrast CT brain scans to help clinicians assess ischemic brain tissue injury and calculate an ASPECTS score, which reflects the extent of stroke-related brain damage. It uses automated image processing and machine learning to highlight affected brain regions, providing decision support for stroke diagnosis and treatment.

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.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.