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

Related Content

Nuance Launches Cloud-Based mPower Clinical Analytics Platform at AHRA 2018
Technology | Analytics Software | August 16, 2018
At the Association for Medical Imaging Management (AHRA) 2018 Annual Meeting and Exposition, July 22-25 in Orlando, Fla...
Doctor-Patient Discussions Neglect Potential Harms of Lung Cancer Screening
News | Lung Cancer | August 15, 2018
August 15, 2018 — Although national guidelines advise doctors to discuss the benefits and harms of...
Intel and Philips Demonstrate CPU Ability in Deep Learning Inference Test Cases
News | Artificial Intelligence | August 15, 2018
Intel and Philips recently tested two healthcare uses for deep learning inference models using Intel Xeon Scalable...
Guerbet Partners With Imalogix on Dose Optimization With Artificial Intelligence
News | Radiation Dose Management | August 14, 2018
August 14, 2018 — Guerbet LLC USA announced a commercial partnership with Imalogix, a provider of...
ACR LI-RADS Steering Committee Releases New Version of CT/MRI LI-RADS
News | Clinical Decision Support | August 13, 2018
August 13, 2018 — The American College of Radiology Liver Imaging Reporting and Data System (LI-RADS) steering commit
Videos | Radiomics | August 09, 2018
A discussion with Martin Vallieres, Ph.D., post-doctoral fellow at McGill University, Montreal, Canada.
Aidoc Receives FDA Clearance for AI Detection of Acute Intracranial Hemorrhage
Technology | Clinical Decision Support | August 08, 2018
Aidoc announced that it was granted U.S. Food and Drug Administration (FDA) clearance for the first product of its...
iCAD Receives FDA Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis
Technology | Breast Density | August 08, 2018
iCAD announced U.S. Food and Drug Administration (FDA) clearance of its latest artificial intelligence (AI) software...
Metro Health-University of Michigan Health Partners With Eon to Improve Lung Cancer Care
News | Oncology Diagnostics | August 07, 2018
Metro Health-University of Michigan Health announced it is partnering with healthcare data company Eon to improve the...
Artificial Intelligence in Medical Imaging to Top $2 Billion by 2023
News | Artificial Intelligence | August 06, 2018
The world market for machine learning in medical imaging is set for a period of robust growth and is forecast to top $2...
Overlay Init