Showing 1191-1200 of 2689 results for "".
- FDA Clears Stereotactic System for Neurologic Surgeries and Procedureshttps://practicalneurology.com/news/fda-clears-stereotactic-system-for-neurologic-surgeries-and-procedures/2470384/The Food and Drug Administration (FDA) has granted 510(k) clearance to the SmartFrame OR Stereotactic System (ClearPoint Neuro, Solana Beach, CA), which consists of the SmartFrame OR, a system that assists in the placement of instruments or devices during neurologic, stereotactic surgeries and pr
- Perfuze’s Millipede Aspiration and Access Catheters Cleared by FDA for Neurovascular Interventionshttps://practicalneurology.com/news/perfuzes-millipede-aspiration-and-access-catheters-cleared-by-fda-for-neurovascular-interventions-1/2470370/Perfuze announced that the second generation of its Millipede 088 access catheter (Perfuze, Galway, Ireland) and its Millipede 070 aspiration catheter (Perfuze, Galway, Ireland) have received Food and Drug Administration (FDA) 510(k) clearance. The Galway, Ireland-based medical device compan
- AI-Enhanced Clinical Decision Support and Patient Workflow Solution for Stroke Cleared by FDAhttps://practicalneurology.com/news/ai-enhanced-clinical-decision-support-and-patient-workflow-solution-for-stroke-cleared-by-fda/2470175/RapidAI (Menlo Park, California), a developer of neurovascular and vascular artificial intelligence (AI)–enhanced clinical decision support and patient workflow solutions, announced it has received FDA 510(k) clearance for Rapid NCCT Stroke. According to the company, Rapid NCCT St
- FDA Clears Parkinson Disease Monitoring Applicationhttps://practicalneurology.com/news/fda-clears-parkinson-disease-monitoring-application/2469942/The Food and Drug Administration (FDA) gave 510(k)clearance to a monitoring application (StrivePD; Rune Labs, San Francisco, ) for Parkinson disease (PD) symptom tracking for use on the Apple Watch. The application’s combination of movement tracking and self-reported symptoms info
- FDA Clears Artificial Intelligence-Assisted Imaging System for Cerebral Aneurysm Detectionhttps://practicalneurology.com/news/fda-clears-artificial-intelligence-assisted-imaging-system-for-cerebral-aneurysm-detection/2469835/The Food and Drug Administration (FDA) gave 510(k) clearance for an artificial intelligence (AI) solution (Viz Aneurysm; Viz.ai, San Francisco, CA) for cerebral aneurysm detection. This imaging solution uses an algorithm to analyze brain imaging and identify cerebral aneurysms, to ensure pa
- Noninvasive Vagus Nerve Stimulation Cleared for Paroxysmal Hemicrania and Hemicrania Continuahttps://practicalneurology.com/news/noninvasive-vagus-nerve-stimulation-cleared-for-paroxysmal-hemicrania-and-hemicrania-continua/2469689/The Food and Drug Administration (FDA) granted 510(k) clearance for the treatment of paroxysmal hemicrania (PH) and hemicrania continua (HC) with noninvasive vagus nerve stimulation (nVNS) (gammaCore; ElectroCore, Rockaway, NJ). This expands the indications for nVNS, which w
- FDA Clears sEEG Electrode Technology for Short-Term Usehttps://practicalneurology.com/news/fda-clears-seeg-electrode-technology-for-short-term-use/2469683/The Food and Drug Administration (FDA) 510(k) granted clearance to market a subsurface EEG (sEEG) electrode (Evo sEEG electrode; NeuroOne, Eden Prairie, MN) for short-term (less than 24 hours) use with for the recording, monitoring, and stimulation of electrical signals at the subsurface level of
- Increased Risk of Dementia Correlates With Decreased Kidney Functionhttps://practicalneurology.com/news/increased-risk-of-dementia-correlates-with-decreased-kidney-function/2469588/In a registry-based study published in Neurology, individuals with reduced kidney function had increased risk of dementia development. In the study, there were cases of dementia per 1,000 person-years in individuals with a normal kidney filtration rate of 90 to 104 mL per minute and with severe k
- FDA Clears Wearable Remote EEG Systemhttps://practicalneurology.com/news/fda-clears-wearable-remote-eeg-system/2469467/The Food and Drug Administration (FDA) gave 510(k) clearance for a remote EEG wearable device (Neuronaute; Icecap; BioSerenity, Atlanta, GA) that will allow physicians to remotely monitor and assess electrical brain activity of individuals as they continue their daily activities. Considering the
- FDA Grants Clearance for Neurovascular Artificial Intelligence Systemhttps://practicalneurology.com/news/fda-grants-clearance-for-neurovascular-artificial-intelligence-system/2469320/The Food and Drug Administration granted a 510(k) clearance for a triage AI solution (Cina Head; Avicenna.AI, La Ciotat, France) for neurovascular emergencies. The FDA's decision covers the automatic detection capabilities for both intracranial hemorrhage (ICH) and large vessel occlusion (LVO