The company’s icobrain software is designed to quantify key features of clinical magnetic resonance imaging brain scans to allow clinicians to monitor changes in their patient’s brains over time.
“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. 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. Max Wintermark of the Stanford University Medical Center said in a press release.
Icometrix said icobrain is the only software currently available that has been scientifically validated and clinically approved for longitudinal measurements.
“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. 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,” icometrix co-founder Dr. Wim Van Hecke said in prepared remarks.
“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,” Dr. Tiron Pechet of Shields Radiology Associates said in prepared remarks.
The post FDA clears icometrix’ MRI quantification software appeared first on MassDevice.
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