icometrix announces FDA clearance for icobrain tbi: first-in-class AI software to segment brain CT scans

LEUVEN, Belgium, and CHICAGO, IL, USA - November 15, 2018 – icometrix, the world leader in software solutions to extract clinically meaningful data from brain scans, is proud to announce to have received an additional FDA 510(k) clearance for icobrain, which now also includes icobrain tbi for Computed Tomography (CT) images. Leveraging deep-learning algorithms, this product is the first CT product available to be applied clinically to help patients with traumatic brain injuries.

Worldwide more than 50 million people suffer a TBI each year and it is estimated that approximately half the world’s population will be subject to one or more TBIs during their lifetime. Attempts to personalize treatment are hampered by the use of qualitative approaches to characterize the nature and severity of TBI. As the first TBI product available for CT, icobrain uses deep learning to quantify clinically important metrics, including hyperdense volumes, cisternal compression and midline shift to better characterise and management of TBI in acute clinical setting.

icometrix is the imaging partner in CENTER-TBI and InTBIR, the pan-European and international TBI research networks respectively, and has brought together expertise from clinicians, and researchers from numerous centers globally to translate this innovation to the clinic.

“The development of this product quantifying CT scans of TBI patients in routine clinical practice helps in the standardized interpretation of acute non-contrast CT scans.” says Prof. Dr. Bart Depreitere, neurosurgeon at UZ Leuven “Up until today TBI was always assessed with the naked eye but this is now complemented by AI technology to provide valuable metrics following clinical guidelines for improved patient care”

“Our quantitative MRI measurements in people with MS, dementia and TBI are used globally and we are receiving a lot of positive feedback from clinicians saying that the reports aid significantly in the treatment of their patients.” says Dirk Smeets PhD, VP Clinical, “It is great to be able to provide a full clinical package with our CT and MRI products for better patient care.”

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