Belgium-based health technology company Icometrix has secured the US Food and Drug Administration (FDA) 510(k) clearance for its image quantification software, icobrain.
icobrain is designed for the automatic labeling and volumetric quantification of the important features of clinical MRI brain scans.
Clinicians are provided with easily interpretable reports in the form of population graphs and statistics which allow them to track changes in the patient’s brain.
icobrain can make an accurate comparison of MRI exams performed at different times using the icometrix patented technology.
Stanford University Medical Center professor of radiology and chief of neuroradiology Dr 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."
Icometrix offers analysis services which assist radiologists and physicians across the world to facilitate an improved and a personalised care of patients with a neurological disorder, such as multiple sclerosis, traumatic brain injury or dementia.
Shields Radiology Associates assistant medical director Dr Tiron Pechet said: "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."