MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device.

According to Gene Saragnese, Chairman & CEO of MedyMatch, the platform is a “first-in-class hemorrhage detection tool.”  The MedyMatch device utilizes artificial intelligence and deep learning technologies to analyze non-contrast head CT images for signs of ICH.  Further implementations of the MedyMatch deep vision platform include diagnosis and monitoring of acute and chronic diseases based on concurrent analysis of imaging data and other patient data.  Vice President of Clinical, Regulatory, and Quality Affairs, Dr. Joshua Schulman, said:

This designation is a recognition of both the need for new assessment tools for intracranial hemorrhage and an affirmation of MedyMatch’s technical approach to assisting clinicians to need to make time-sensitive yet accurate decisions in emergency settings.

The EAP Program, intended to speed approval of certain medical devices, generally includes priority review, more interactive review, and senior management involvement.  EAP designation can be awarded for devices that address unmet needs for treatment or diagnosis of life-threatening or irreversibly debilitating conditions.    It is said to be expected that EAP designated devices will be transitioned to the new Breakthrough Devices program established under the 21st Century Cures Act of 2016.

Jordan Gottdank
Jordan Gottdank is an associate in our San Diego office. His practice focuses on patent prosecution and litigation. Mr. Gottdank earned his J.D. from UCLA School of Law, where he co-founded the Intellectual Property Law Association and worked as a research assistant in the fields of intellectual property law and international environmental regulation. While in law school, Mr. Gottdank served as a judicial extern for four judges in the U.S. District Court for the Central District of California, working exclusively on patent cases. He has experience in a wide range of fields, including electronics, communications technology, optics, medical devices, transportation, apparel, and sporting goods. Mr. Gottdank worked as a summer associate at the firm in 2014 and joined the firm in 2015.
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