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Epica Gains FDA Clearance for SeeFactorCT3

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Epica was granted FDA 510(k) clearance to market the SeeFactorCT3™ Imaging Platform. SeeFactorCT3 comprises computed tomography (CT), fluoroscopy and digital radiography in one system.

The diagnostic, interventional and intraoperative imaging system can obtain ultra high-resolution 3D volumetric images throughout the body, and can serve as a primary imaging modality for practically all musculoskeletal applications.

Epica's HDVI (High Definition Volumetric Imaging) is a hybrid technology in CT. Conventional CT samples densities within a patient’s anatomy, providing axial sliced data, leaving gaps in the data between each slice that are then reconstructed using interpolation. It is then rendered in axial and coronal data sets, with a different resolution on each side. HDVI technology scans a solid volume of data at a time, resulting in gapless data, with no need for interpolation. HDVI delivers a 3D map of densities with spacial resolution that is the same in all three dimensions, with contrast equivalent to conventional CT. 

​This volume of data can provide resolution as small as 0.09mm (about the thickness of a human hair). Clinicians can view the data in any angle, thickness or orientation, supporting diagnostic confidence.

SeeFactorCT3 features a detachable patient table/chair with a sterile drape for interventional procedures. The system is lightweight and maneuverable, and is suitable not only for imaging or operating rooms, but also ambulatory/outpatient centers and emergency rooms.

Having obtained FDA clearance, the company will now focus on development of a medical robot to integrate with CT imaging. The connection would allow the robot to be guided by SeeFactorCT3’s ultra-high resolution images. 

Source: Epica International, Inc.