Icometrix has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for their image quantification software, Icobrain. Icobrain is designed to quantify key features of clinical magnetic resonance imaging (MRI) brain scans, enabling clinicians to monitor how their patient’s brain changes 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”, says Max Wintermark, professor of Radiology and chief of Neuroradiology at the Stanford University Medical Center (Stanford, USA).
Tiron Pechet, assistant medical director of Shields Radiology Associates, says, “The MRI reports created by Icometrix are already being used by hundreds of neurologists and radiologists outside the USA. The clearance by the FDA is a major step forward for physicians and patients across the nation.”