The US Food and Drug Administration (FDA) has granted expedited access pathway (EAP) / breakthrough device designation to Israeli firm MedyMatch Technology’s artificial intelligence (AI) based software designed to detect intracranial haemorrhage (ICH).
The software leverages deep learning technologies to automatically analyse non-contrast head CT images, which are considered as the standard for initial assessment of possible ICH in emergency medicine settings.
Said to be sensitive to the presence of ICH in these scans, the AI software will notify the physician upon detection of a bleed.
MedyMatch Clinical, Regulatory and Quality Affairs vice-president Dr Joshua Schulman said: “FDA’s Expedited Access Pathway and Breakthrough Device designation gives us the opportunity to accelerate the development and approval process of our intracranial haemorrhage software in the US.
“This designation is recognition of both the need for new assessment tools for intracranial haemorrhage and an affirmation of MedyMatch’s technical approach to assisting clinicians who need to make time-sensitive yet accurate decisions in emergency settings.”
The firm’s machine vision and deep learning platform is intended to support evaluation of various clinical indications.
A team of AI, deep learning, and machine vision experts from MedyMatch have collaborated with clinical and industry partners to gain an understanding of medical data and use it for different medical applications such as the identification of ICH.
MedyMatch chairman and CEO Gene Saragnese said: “As the population grows older and lives longer and as more treatment options become available, MedyMatch is positioned to assist clinicians in making assessments that can ultimately save lives and minimise disability while utilising healthcare resources in the best way possible.”