The FDA has given 510(k) clearance to icometrix for icobrain, the company’s image quantification software. Clinicians can use the software to monitor how their patient’s brain changes over time. This is the only currently available software that has been scientifically validated and clinically approved for longitudinal measurements. Additionally, the software gives clinicians access to a wide variety of unique information about disease progression and the effect of treatment on brain structure.
Radiologists and other physicians can use icometrix’ analysis services to personalize the care of their patients with neurological disorders such as traumatic brain injury, dementia, or multiple sclerosis.
“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 Max Wintermark, MD, professor of radiology and chief of neuroradiology at the Calif-based Stanford University Medical Center.
The co-founder of icometrix, Wim Van Hecke, PhD, says: “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.”
For more information about this technology, visit icometrix.