News | Computed Tomography (CT) | February 01, 2018

MedyMatch Receives FDA Device Designation for Intracranial Hemorrhage Software

Software designed to be highly sensitive to the presence of intracranial hemorrhage (ICH) and alert the treating physician when ICH is detected

MedyMatch Receives FDA Device Designation for Intracranial Hemorrhage Software

February 1, 2018 – MedyMatch Technology, a company focused on helping physicians provide accurate patient assessment through artificial intelligence (AI)-based insights, announced that it has been granted Expedited Access Pathway (EAP) designation by the United States Food and Drug Administration (FDA) for intracranial hemorrhage detection.

This software medical device, based on deep learning technologies, automatically analyzes non-contrast head computed tomography (CT) images.  It is designed to be highly sensitive to the presence of intracranial hemorrhage (ICH) in these scans and to alert the treating physician when ICH is detected.  Non-contrast head CT is the standard for initial assessment of potential ICH in emergency medicine settings. Accurate and timely detection of ICH is a critical step in clinical decision making for stroke assessment and head trauma.  

The EAP program is designed to facilitate rapid patient access to medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Under the 21st Century Cures Act, EAP devices will be transitioned to FDA's Breakthrough Device program.

MedyMatch has developed a broad machine vision and deep learning platform to support the assessment of multiple clinical indications. MedyMatch's team of AI, deep learning and machine vision experts is working with clinical and industry partners to yield unprecedented insights into medical data.  The first of these applications will be the detection of intracranial hemorrhage.  

For more information: www.medymatch.com

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