FDA Clears icometrix’ Image Quantification Software to Monitor Neurological Disorders

After opening a subsidiary in the Boston, Mass., area earlier this year, Belgian health tech company icometrix has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its image quantification software, icobrain. icobrain quantifies key features of clinical magnetic resonance imaging (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 access to information about disease progression and the effect of treatment upon brain structure.
 
“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”, said Dr. Max Wintermark, M.D., professor of radiology and chief of neuroradiology at 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.”
 
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 U.S. 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 physicians, neuroradiologists and patient organizations worldwide in order to provide the most clinically helpful MRI measures”, said 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, and the establishment of a subsidiary in the Boston area, 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, a radiology network with more than 30 locations in New England, agrees: “The MRI reports created by icometrix are already being used by hundreds of neurologists and radiologists outside the U.S. 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.
 
“We are thrilled to welcome icometrix to Massachusetts and congratulate the company on their 510(k) clearance,” said Robert K. Coughlin, president and CEO of MassBio, the life sciences trade association. “This technology—and personalized medicine broadly—represents the future of healthcare, where doctors can monitor patient’s individual disease progression and act with appropriate and sometimes life-saving interventions. We welcome icometrix to our burgeoning personalized medicine and digital health ecosystem.”
 
“Congratulations to icometrix on establishing their first U.S. office here in Massachusetts, the world’s number one ecosystem for life sciences innovation & growth,” said Travis McCready, president and CEO of the Massachusetts Life Sciences Center. “With FDA clearance in hand for their icobrain technology, this company is poised to make a difference in the quality of care for patients and in the Massachusetts innovation economy. We look forward to being a good partner as icometrix puts down roots and grows here in the Commonwealth.”
 
“icometrix has achieved an important milestone in its plan to expand its presence here in the U.S. The FDA clearance, along with its decision to establish a U.S. beachhead in Massachusetts, should position the company well for future success,” said Thomas J. Sommer, president of Massachusetts Medical Device Industry Council (MassMEDIC).
 
icometrix was founded in 2011 by Dirk Loeckx and Hecke as a spin-off company of the Belgian universities and university hospitals of Leuven and Antwerp. Today, icometrix is internationally active, with offices in Leuven (Belgium) and Boston. 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.