ENDRA Life Sciences Inc. and Thermo Acoustic Enhanced UltraSound (TAEUS®), announced an update to its plan to submit a De Novo request for the TAEUS system to the U.S. Food and Drug Administration (FDA). The TAEUS system is intended to characterize fatty liver tissue as a means to non-invasively assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). TAEUS is already approved for sale in countries that recognize the CE mark, including those in the European Union.

The De Novo request provides a pathway in the United States for an entirely new product classification and, if granted, promises to strengthen TAEUS' competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to characterize NAFLD, which impacts over one billion people globally.