NDRA - ENDRA to submit FDA De Novo request for liver disease monitoring system in coming weeks
- ENDRA Life Sciences ( NASDAQ: NDRA ) on Thursday said it would submit a De Novo request to the U.S. FDA in the coming weeks for its TAEUS liver disease monitoring system.
- The FDA's De Novo process gives companies a pathway to classify medical devices which are not already based on a legally marketed device and for which general controls provide reasonable assurance of safety and effectiveness.
- "I'm pleased to announce that preparation of the De Novo documentation by the end of the third quarter is substantially complete," NDRA CEO Francois Michelon said in a statement .
- The company's TAEUS system characterizes fatty liver tissue, thus allowing one to monitor for non-alcoholic fatty liver disease.
- NDRA said the system was already approved for sale in countries that recognize the CE Mark, including those in the European Union.
- ENDRA ( NDRA ) stock earlier closed +4.2% at $0.32.
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ENDRA to submit FDA De Novo request for liver disease monitoring system in coming weeks