Elucid Bioimaging Inc, announced today that it has received FDA 510(k) clearance to market its vascuCAP software (K163071) for evaluating CT images of patients with atherosclerosis.May 25, 2017
May 25th, 2017 Wenham Massachusetts – Elucid Bioimaging Inc, announced today that it has received FDA 510(k) clearance to market its vascuCAP software (K163071) for evaluating CT images of patients with atherosclerosis.
“This is a major milestone in the Elucid’s commercialization program”, remarked John Garber, Chief Executive Officer, “our visualization and measurement tools will be available for clinical care and clinical trials use. Furthermore, our research partners can now be confident in the translational value of the insights they obtain with the assistance of the tissue characterization and measurements available from vascuCAP”.
“We would like to thank the radiology, surgical and pathology researchers participating in our Q-CAMP study for their careful collection, analysis and management of our human subject validation data,” said Andrew Buckler, President and Chief Technology Officer, “We are especially grateful for the leadership of our principal investigator, Dr. Malachi Sheahan, Program Director for Vascular Surgery at Louisiana State University.”
vascuCAP is an image analysis software package for evaluating CT images of arterial vessels ≥ 4.5mm in diameter. It allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from CT scanners. vascuCAP provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and tissue characteristics. The vascuCAP software application user interface follows typical clinical workflow patterns to process, review, and analyze digital images.
Indications for use:
vascuCAP is a medical image analysis system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired with contrast from CT imaging devices. vascuCAP is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. The software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels ≥ 4.5mm in diameter. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard vascuCAP software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Hounsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views. The measurements provided by vascuCAP are not intended to provide a diagnosis or clinical recommendations. vascuCAP is intended as a tool to complement standard of care.