ENDRA to Submit De Novo Request to U.S. FDA for Imaging System

 -ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces an update to its plan to submit a De Novo request for the TAEUS system to the U.S. Food and Drug Administration (FDA).

"I’m pleased to announce that preparation of the De Novo documentation by the end of the third quarter is substantially complete," said ENDRA's Chairman and Chief Executive Officer Francois Michelon. "Our remaining efforts are focused on the TAEUS and MRI confirmatory data portion of the submission with ENDRA's clinical collaborators, and we expect to submit the De Novo request in the coming weeks. We appreciate the continued support of shareholders as we believe the De Novo process will assist ENDRA in achieving the strongest market position in the United States with TAEUS-optimized claims."

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.

https://finance.yahoo.com/news/endra-life-sciences-plans-submit-200500272.html