Neurosurgery
FDA: Class I recall of Imperative Care ZOOM 71 Reperfusion Catheter
Editor's Note The Food and Drug Administration (FDA) on October 6 identified the recall by Imperative Care Inc of its ZOOM 71 Reperfusion Catheter as Class I, the most serious. The ZOOM 71 Reperfusion Catheter is used to remove blood clots from a patient’s brain within 8 hours of an…
FDA: Class I recall of Medtronic Pipeline Flex Embolization devices
Editor's Note The Food and Drug Administration (FDA), on September 20, identified Medtronic’s recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology as Class I, the most serious. The devices, which are used to treat brain aneurysms, were recalled because there is a risk…
Joint Commission extends reduced volume requirements for advanced stroke certification programs
Editor's Note The Joint Commission on March 3 announced that it is extending the reduced volume eligibility requirements for its advanced Thrombectomy-Capable Stroke Center (TSC) and Comprehensive Stroke Center (CSC) certification programs through May 31 because the number of patients seeking care for strokes continues to vary because of COVID-19.…
ACS opposes proposed Medicare physician fee schedule
Editor's Note The American College of Surgeons (ACS) on August 4 announced that it is strongly opposed to the Centers for Medicare & Medicaid Services (CMS) Physician Fee Schedule proposed rule for CY 2021. In the fee schedule, which is set to take place January 1, 2021, Medicare payments will…
ACS issues statement on maintaining emergency care system during COVID-19 pandemic
Editor's Note As hospitals face a surge of COVID-19 patients, the ability for them to care for trauma cases and medical and surgical emergencies is severely compromised. Because of this, the American College of Surgeons (ACS) on April 7 issued a statement calling for strategies to preserve capacity and capability…
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…
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