The health tech company icometrix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their image quantification software. Outside the US, the software is already extensively used and offered via MSmetrix.
The software quantifies key features of clinical MRI brain scans, which enable clinicians to monitor how their patient’s brain changes over time, which is especially useful for Multiple Sclerosis. icometrix' software is the only solution currently available that has been scientifically validated and clinically approved for longitudinal measurements. This way, icometrix offers clinicians unrivalled access to unique 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”, 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 Multiple Sclerosis or other neurological disorders. 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 United States.”
