FDA clears icometrix' image quantification software to monitor neurological disorders
BOSTON, Sept. 8, 2016 /PRNewswire/ -- The health tech company icometrix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their image quantification software, icobrain. icobrain quantifies key features of clinical MRI brain scans, which enable clinicians to monitor how their patient's brain changes over time. As the only software currently available that has been scientifically validated and clinically approved for longitudinal measurements, icobrain offers clinicians unrivalled access to unique information about disease progression and the effect of treatment upon brain structure.
To measure is to know
"MRI biomarkers are becoming of vital importance in the clinical care path for various pathologies including neurological disorders such as multiple sclerosis, traumatic brain injury and stroke. It is of paramount importance that the biomarker measurements are extremely reproducible and sensitive enough to detect relevant clinical changes", says Dr. Max Wintermark, M.D., Professor of Radiology and Chief of Neuroradiology at the Stanford University Medical Center. "The icometrix methods have been published in several scientific journals and validated by top centers worldwide, demonstrating the accuracy that is needed to translate measures from a research setting to routine clinical practice", Dr. Wintermark adds.
icometrix' analysis services help radiologists and physicians worldwide to improve and personalize the care of patients with a neurological disorder, such as multiple sclerosis, traumatic brain injury or dementia. Accessing the US market is an important step and will lead to more evidence-based medicine by bringing automated MRI reports into clinical practice.
"From the outset, icometrix has developed its software in collaboration with leading physicians, neuroradiologists and patient organizations worldwide in order to provide the most clinically helpful MRI measures", says Dr. Wim Van Hecke, co-founder of icometrix. "In doing so, we have established ourselves as a market leader in Europe, Canada, South America and Australia. The FDA clearance will now allow us to also help patients and their clinicians in the United States". Dr. Tiron Pechet, M.D., Assistant Medical Director of Shields Radiology Associates, agrees: "The MRI reports created by icometrix are already being used by hundreds of neurologists and radiologists outside the US. The clearance by the FDA is a major step forward for physicians and patients across the nation."
icobrain is highly reliable software for the automatic labeling and volumetric quantification of MRI brain scans. It is offered as a service by icometrix and qualifies for reimbursement under CPT code 76377 in the US. Starting from a clinical MRI scan, icobrain provides an easily interpretable report to clinicians, including population graphs and statistics that can be used to objectively track the disease progression of individual patients. One of the unique features of icobrain is that the software can accurately compare MRI exams acquired at different times, using icometrix patented technology.
icometrix was founded in 2011 by Dirk Loeckx and Wim Van Hecke as a spin-off company of the leading Belgian universities and university hospitals of Leuven and Antwerp. Today, icometrix is internationally active, with offices in Leuven (Belgium) and Boston (US). In 2015, icometrix' clinical product received market approval in Europe, Canada, South America and Australia. In addition, icometrix' technology is increasingly used as an endpoint in clinical trials and large international research studies. icometrix is ISO9001 and ISO13485 (Medical Devices), ISO27001 (Information Security) certified and HIPAA compliant regarding Security and Privacy Rules.
More informationAnke Maertens, Marketing Manager firstname.lastname@example.org, +32 499 10 58 56
Eline Van Vlierberghe, Associate Director USAeline.email@example.com, +1 617 513 7301
Wim Van Hecke , co-founder, Chief Business Officerwim.firstname.lastname@example.org, +32 484 92 73 00
Dirk Smeets, Chief Scientific Officerdirk.email@example.com, +32 495 80 16 46
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