ENDRA Life Sciences Submits De Novo Request For Its TAEUS System Liver Fat Application To The U.S. FDA
Portfolio Pulse from Happy Mohamed
ENDRA Life Sciences Inc. has submitted a De Novo request to the U.S. FDA for its Thermo Acoustic Enhanced UltraSound (TAEUS) system, a device for non-invasive assessment of fatty liver tissue. The submission includes data from clinical studies comparing TAEUS with MRI-PDFF, showing a sensitivity of 90% and a strong correlation. The company believes the TAEUS system could fulfill an unmet need for a non-invasive, cost-effective tool for fatty liver disease assessment.
August 14, 2023 | 5:31 pm
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ENDRA's submission of the De Novo request to the FDA for its TAEUS system could potentially lead to a new product classification. If approved, this could significantly boost the company's market position.
The FDA approval of the TAEUS system could open up a significant market opportunity for ENDRA, as it offers a non-invasive, cost-effective solution for fatty liver disease assessment. This could potentially lead to increased revenues and a stronger market position for the company.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 100