Neurosurgery
Laser-based imaging system, AI algorithm accurately identify brain tumors
Editor's Note Researchers at NYU Langone Health combined advanced optical imaging with an artificial intelligence (AI) algorithm to produce accurate, real-time intraoperative diagnosis of brain tumors in this study. Compared with the accuracy of pathologists’ interpretation of conventional histologic images, the results for both methods were comparable. The AI-based diagnosis…
FDA: Class I recall of LivaNova VNS Therapy SenTiva Generator
Editor's Note The Food & Drug Administration (FDA) on January 2 identified the recall by LivaNova of its VNS Therapy SenTiva Generator System as Class I, the most serious. The recall was initiated because of an unintended reset error that causes the system to stop delivering vagus nerve stimulation therapy…
AI algorithms predict mortality after traumatic brain injury
Editor's Note Two artificial intelligence-based algorithms predicted the probability of a patient dying in the ICU within 30 days of traumatic brain injury with accuracies up to 81% and 84%, in this study from Finland. The first algorithm is based on objective monitor data, and the second one includes data…
FDA: Class I recall of Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System
Editor's Note The Food & Drug Administration on November 7 identified the recall by Zimmer Biomet of its ROSA Brain 3.0 Robotic Surgery System as Class I, the most serious. The recall was initiated because of a software issue that incorrectly positions the robotic arm. The company has received five…
FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems
Editor's Note The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious. The recall was initiated because of…
FDA grants Stryker premarket approval for intracranial aneurysm stent
Editor's Note Stryker announced on May 20 that the Food & Drug Administration (FDA) granted premarket approval for its Neuroform Atlas stent system for intracranial aneurysms, the May 20 MassDevice reports. The self-expanding nitinol stent can now be used with neurovascular embolization coils to treat patients with saccular wide-necked…
FDA: Class I recall of Neuro Omega System
Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…
FDA issues Safety Communication for Stryker Wingspan Stent System
Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Communication on use of the Stryker Wingspan Stent System outside of approved indications. The Wingspan Stent System is used to open narrowed arteries in the brains of patients with intracranial stenosis who are experiencing repeated strokes.…
FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software
Editor's Note The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious. The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s…
FDA: Class I recall of Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration
Editor's Note The Food and Drug Administration (FDA) on November 30 identified the recall by Synaptive Medical of its BrightMatter Guide with SurfaceTrace Registration, which is used to perform neurosurgical procedures, as Class I, the most serious. The recall was initiated because of a software defect that could potentially result…
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