Neurosurgery
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…
FDA sends letter to healthcare providers on neurovascular stents
Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…
Allowing overlapping surgery for urgent neuro cases decreases length of stay
Editor's Note A change of policy to allow the practice of overlapping surgery for urgent neurosurgical procedures in a tertiary care, safety-net hospital significantly reduced length of stay, in this study presented May 1 at the American Association of Neurological Surgeons in New Orleans. Of 452 cases analyzed (201 in…
FDA issues Safety Alert for magnetic resonance-guided laser interstitial thermal therapy devices
Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Alert that provides preliminary information concerning magnetic resonance (MR) thermometry reliability with MR-guided laser interstitial thermal therapy (MRgLITT) devices. The FDA is evaluating data that suggests potentially inaccurate MR thermometry information can be displayed during treatment,…
FDA: Potential for increased image artifact when using MRA for follow-up of embolization coil procedures
Editor's Note The Food & Drug Administration (FDA) on March 12 issued a Safety Alert on the potential for increased artifact associated with magnetic resonance angiography (MRA) imaging for follow-up of certain post neurovascular embolization coil procedures. When MRA is performed on patients implanted with neurovascular embolization coils containing 304V…
FDA permits marketing of new blood test for concussions
Editor's Note The Food & Drug Administration (FDA) on February 14 authorized marketing of the first blood test to help evaluate concussions in adults and reduce the need for CT scans. The Banyan Brain Trauma Indicator works by measuring levels of proteins (ie, UCH-L1 and GFAP) that are released from…
Neurosurgical products market poised for growth
Editor's Note Wise Guy Reports predicts the global market for neurosurgical products will see a 10.5% compound annual growth rate through 2023 because of the growing availability of neurosurgical devices and increasing popularity of minimally invasive surgeries, the February 9 Becker’s Spine Review reports. Key players in the market, which…
FDA permits marketing of software to alert providers of potential strokes in patients
Editor's Note The Food & Drug Administration (FDA) on February 13 announced that it is permitting the marketing of clinical decision support software that alerts providers to potential strokes in their patients. The Viz.AI Contact application is designed to analyze computed tomography images of the brain and send a text…
Landmark study may affect stroke treatment guidelines
Editor's Note Guidelines for stroke treatment currently recommend clot removal within 6 hours of onset. However, a new study led by researchers from Emory University School of Medicine, Atlanta, finds that clot removal up to 24 hours leads to significantly reduced disability. This international multi-center study randomly assigned 206 stroke…
Study: Overlapping surgery is safe
Editor's Note Overlapping surgery can be safely performed without risking patient safety, this study from Emory University Hospital finds. Of 2,275 neurosurgical cases included in the analysis, 1,303 were overlapping and 972 were nonoverlapping. The researchers found no difference between overlapping and nonoverlapping neurosurgical procedures in terms of 90-day postoperative…
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