by Lisa Chamoff
, Contributing Reporter | September 30, 2019
From the September 2019 issue of HealthCare Business News magazine
The product is FDA 510(k) pending and Hitachi plans to showcase it at this year’s RSNA.
iCRco inc.’s latest product, the ClarisXT, is a multi-modality device that provides high-resolution 3D imaging, as well as full-field diagnostic X-ray. ClarisXT replaces a traditional X-ray system in an orthopedic, sports medicine or medical clinic. The system is designed for general X-ray applications, orthopedic imaging, bones and joints, as well as head and neck studies.
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ClarisXT provides four times better resolution than traditional CT, at a third of the dose, said Stephen Neushul, president, chief executive officer and head engineer of iCRco.
“Regular CT sensors are small-tiled arrays, with 600-pixel micron spacing,” Neushul said. “Our system has a single large area detector with pixel spacing of 140 microns.”
In 2012, the company obtained an FDA 510(k) clearance for an earlier device, the ClarisCBCT, and iCRco is now in the process of obtaining FDA 510(K) allowance for the new device, which it says has a larger diagnostic reconstructive volume.
The ClarisXT is a lightweight, portable CT solution that includes a workstation with review capability, a movable gantry and movable table, and is capable of full-field diagnostic X-ray imaging as well as CT. It comes with ClarityPACS and ClarityPractice for scheduling patients, reviewing, reporting, storage and billing.
“The ClarisXT is the result of eight years of development, and almost 30 years of involvement in the medical imaging field,” Neushul said. “We will introduce this device into portable applications, orthopedic practices and small clinics, and eventually we hope to use it for Spine surgeons and for lung nodule screening. We are bringing CT technology to a level that will allow traditional X-ray users to expand their imaging capability to include 3D imaging. ClarisXT is a low-dose, high resolution system, with a guided workflow interface, simplifying the acquisition process. This new device will provide an exciting opportunity to improve patient care at all levels.”
NeuroLogica, a healthcare subsidiary of Samsung Electronics Co. Ltd., has partnered with Winnebago Specialty Vehicles to increase access to mobile CT clinics across the U.S.