Neuisys Announces FDA Clearance Of UroCARE

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals;  MRI / PET / Ultrasound;  IT / Internet / E-mail
Article Date: 28 Apr 2009 - 1:00 PDT

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Neuisys, a leader in providing state-of-the-art CT and MR imaging systems to physician practices, announced today at the annual meeting of the American Urological Association that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of UroCARE(TM), a unique software application package for the assessment of urinary anatomy using multi-slice computed tomography (CT) data.

UroCARE is an exclusive software package developed by Neusoft Medical Systems for the NeuViz Dual and NeuViz 16 CT systems. UroCARE is also compatible with DICOM compliant CT image sets, including those from other CT manufacturers.

"The team at Neusoft is very proud to be at the forefront of clinical applications development for high-tech medical imaging," said Dr. Yan Kang, Vice President and General Manager of Medical IT at Neusoft. "The FDA clearance of UroCARE is an exciting milestone in Neusoft's development of computer assisted reading and evaluation (CARE) packages, and we must share the credit with our clinical partners who have helped our software engineers understand their specific needs from an anatomic and disease process point of view."

UroCARE uses proprietary image processing algorithms to analyze multi-phase CT images of the urinary tract. Its advanced clinical functionality provides a KUB (kidney, ureter, and bladder) view; automatic segmentation of kidneys, ureters, and bladder; and detection of urinary calculi with density and volume measurements. KUB radiography has long been a key part of the daily routine for urology practices. UroCARE's KUB-view can eliminate the need for a dedicated radiography room or the need for patient to go to another facility for a KUB.

"UroCARE was specifically designed for the urologic surgeon to facilitate decision making for ureteroscopy or lithotripsy," said Dr. Edward Janosko of Atlantic Urology in Wilmington, North Carolina and former Chief of Urology at Pitt Memorial Hospital/East Carolina University School of Medicine. "UroCARE enables the display of the entire collecting system as a 3-D pyelogram, which urologists are accustomed to reviewing for the detection of filling defects and to separate phleboliths from stones. UroCARE can also assist with the selection of an optimal percutaneous tract for nephrostolithomy. All of these capabilities are completed with a few clicks of the mouse. I know of no other system that can do this."

About Neuisys

Neuisys Imaging Systems Solutions, headquartered in Greensboro, North Carolina, is a leader in providing state-of-the-art CT and MR imaging systems to physician practices, community hospitals, and imaging centers. Neuisys is the North American distributor for Neusoft(R) Medical Systems and markets an array of products including the NeuViz Dual and NeuViz 16 multi-slice CT systems, the SuperStar HD open MRI system, multi-modality advanced visualization workstations, image management solutions, digital x-ray, and ultrasound products.

Source: Neuisys Imaging Systems Solutions

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