The US Food and Drug Administration has given 510(k) clearance to icobrain, an image quantification software developed by Belgium-based icometrix, which can help in monitoring neurological disorders.
The software can quantify key features of clinical MRI brain scans, which help clinicians in monitoring how a patient’s brain can change over time. Icometrix claims that Icobrain is the only software that has been scientifically validated and clinically approved for longitudinal measurements.
It also says that the software provides clinicians with an unparalleled access to unique information about disease progression and the effect of treatment on the brain structure.
Icometrix further says that the icobrain software can help clinicians and physicians worldwide to improve and personalise the care for patients with neurological disorders such as multiple sclerosis, traumatic brain injury or dementia.
The software can automate MRI reports into clinical practice. And it is critical for the company to enter into US market where it could lead the industry towards evidence-based medicine.
Stanford University Medical Center Neuroradiology Chief and Radiology Professor Max Wintermark said: "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."