FDA clears Epica's multi-modality mobile CT scanner, SeeFactorCT3
October 09, 2019
by John R. Fischer
, Senior Reporter
The FDA has given Epica International the OK to begin distributing its multi-modality mobile CT scanner, SeeFactorCT3.
The imaging platform is composed of three integrated systems for CT, fluoroscopy and digital radiography, all of which can be used for diagnostic, interventional and intraoperative procedures to obtain ultrahigh-resolution 3D volumetric images.
"Given our multi-modality and mobile imaging platform's ultra-high resolution (in soft and hard tissue), lower cost of ownership, less infrastructure preparation, lower radiation dose, and an ability to move our lightweight platform to the patient, we expect the diagnostic and intraoperative imaging platform to be adopted by physicians, surgeons, interventional radiologists in outpatient settings, ER/Trauma areas and acute care environments," Daniel Naimey, senior vice president of business development, strategy and marketing at Epica International told HCB News. "We also expect significant adoption from ortho and neuro specialists."
The scanner compiles and produces data in an interpolated fashion, making images real and sliceless. They carry an isotropic image resolution as fine as 0.1 mm in both soft and hard tissue, with the scanner able to detect lesions as small as 0.2 mm. It also is equipped with Epica’s “Pulsed Technology” to reduce radiation dose received by patients and healthcare professionals, as well as a detachable patient table/chair, and sterile drape for interventional procedures.
The SeeFactorCT3 provides 2D and 3D images for each anatomical region. With its dynamic flat-panel sensor technology, users can scan sequences of the head including the ear, nose and throat (ENT); the dento-maxillofacial complex; teeth; mandible and jaw; and temporo-mandibular joint (TMJ); other areas of the human skull and neck with sections of upper cervical spine; and upper and lower extremities for diagnostic and intraoperative support.
A lightweight device, the system is maneuverable through hallways, normal-sized doors, and can be used to convert unused rooms into cost-effective, multi-modality, diagnostic and therapeutic imaging areas within ambulatory/outpatient centers (ASC), imaging centers or ER/Trauma areas of a hospital. It can also be moved into the ICU, ER/Trauma areas, imaging room or operating room.
Along with the release of SeeFactorCT3, the company is continuing to develop its Medical Robot prototypes, which will be an integration of an Epica CT and an Epica Surgical Assist Robot. Both are mechanically linked and controlled by the company’s proprietary software control system and capable of providing system stability and surgical accuracy. With their open-architecture systems, the prototypes will enable physicians to visualize target anatomy, plan surgical intervention, and complete procedures with the surgeon’s preferred instruments at lower dose and cost, with robotic high precision.
"The non-interpolated (gapless, all real), isotropic nature of the 3D images obtained from Epica's CT provides the system with incredibly accurate measurements. The surgical assist robot planning movements are guided by those measurements leading the combined platform to be intrinsically more accurate than other robot systems currently on the market," said Naimey. "This linkage creates a platform that is extremely stable and precise with vastly simplified registration."
The company expects to submit Epica's Surgical Assist Robot for regulatory review during the second half of 2020.