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FDA Clears Updated 3D Imaging Guidance for Spine Surgery
The second-generation version of the VUZE System reportedly offers expanded functionality and incorporation of varied sources of 3D imaging data, including cone-beam CT scans obtained in the OR.
The Food and Drug Administration (FDA) has granted 510(k) clearance for a second-generation update of the VUZE System, which overlays positioning of surgical tools from intraoperative X-rays onto cross-sectional, pre-operative computed tomography (CT) scans.
VUZE Medical, the manufacturer of the VUZE System, emphasized that the new version of the software can be utilized with a larger range of surgical C-arm devices. The company added that the updated VUZE system may incorporate 3D imaging source data from cone-beam CT scans obtained in the operating room as well as pre-operative CT imaging.
The second-generation update of the VUZE system, which overlays positioning of surgical tools from intraoperative X-rays onto cross-sectional, pre-operative computed tomography (CT) scans, has garnered 510(k) clearance from the Food and Drug Administration (FDA). (Images courtesy of VUZE Medical.)
Expanded functionality with the second-generation version of the software also enables surgical planning on compatible standalone laptops, according to VUZE Medical.
“Our second generation significantly extends the applicability of the VUZE System across desired surgical workflows and operating room setups,” said David Tolkowsky, the founder and CEO of VUZE Medical. “In each of those situations, our aim is to preserve the advantages of common X-ray guidance while addressing its shortcomings.”
While noting a current focus of the VUZE System in facilitating minimally invasive thoracolumbar stabilizations, VUZE Medical said it plans to pursue additional clearances for spinal and skeletal interventions.
CT Study Reveals Key Indicators for Angiolymphatic Invasion in Non-Small Cell Lung Cancer
January 15th 2025In computed tomography (CT) scans for patients with solid non-small cell lung cancer (NSCLC) < 30 mm, emerging research suggests the lollipop sign is associated with a greater than fourfold likelihood of angiolymphatic invasion.
New CT and MRI Research Shows Link Between LR-M Lesions and Rapid Progression of Early-Stage HCC
January 2nd 2025Seventy percent of LR-M hepatocellular carcinoma (HCC) cases were associated with rapid growth in comparison to 12.5 percent of LR-4 HCCs and 28.5 percent of LR-4 HCCs, according to a new study.
Can Radiomics Bolster Low-Dose CT Prognostic Assessment for High-Risk Lung Adenocarcinoma?
December 16th 2024A CT-based radiomic model offered over 10 percent higher specificity and positive predictive value for high-risk lung adenocarcinoma in comparison to a radiographic model, according to external validation testing in a recent study.
