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ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA
ANN ARBOR, Mich.--(BUSINESS WIRE)-- ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound
About this update from Endra Life Sciences Inc.
[{"type":"text","content":" ANN ARBOR, Mich.--(BUSINESS WIRE)--\nENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA). The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).\n\n\n“We are very pleased that our FDA De Novo submission has advanced to the substantive review stage,\" stated ENDRA's Chairman and Chief Executive Officer Francois Michelon. \"ENDRA is committed to bringing the TAEUS technology to the U.S market to help clinicians combat the global epidemic of fatty liver disease, which affects over one billion people globally. We look forward to supporting the FDA as they continue their review.\"\n\n\nOn August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system. On August 29, 2023, FDA informed ENDRA that the Company's submission was entering the substantive review period. The FDA's goal is to make a decision about a De Novo request in 150 review days.\n\n\nThe De Novo pathway provides a way to classify novel medical devices for which there is no legally marketed predicate device and if granted, will strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of NAFLD.\n\n\nAbout ENDRA Life Sciences Inc.\n\n\nENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with over 500,000 ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor Steatotic Liver Disease (SLD) (formerly known as NAFLD-NASH), a chronic liver spectrum that affects over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEU...