ENDRA Life Sciences Reports TAEUS Device Matches MRI Accuracy in Liver Disease Study

Reuters12-04

ENDRA Life Sciences Reports TAEUS Device Matches MRI Accuracy in Liver Disease Study

ENDRA Life Sciences Inc. has announced new results from a recently completed feasibility study of its TAEUS® Liver device, designed for the early detection and monitoring of steatotic liver disease (SLD). The study, which included 40 subjects with a BMI range of 21 to 47, demonstrated that the TAEUS thermo-acoustic fat fraction (TAFF) measurement closely matches the performance of MRI-PDFF, the current gold standard, at key liver fat fraction (LFF) thresholds of 12-17% and 20-22%. These thresholds are significant for clinical therapy decisions and clinical trial enrollment. The device achieved an average positive predictive value (PPV) of 100% and accuracy of 95% in the 12-17% LFF range, and a PPV of 90% and accuracy of 94% in the 20-22% range. ENDRA is conducting a second feasibility study in London, Ontario, Canada, expected to be completed in the coming months, and plans to engage with the FDA in 2026 regarding a pivotal study to support a De Novo submission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. ENDRA Life Sciences Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251204350283) on December 04, 2025, and is solely responsible for the information contained therein.

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The study, which included 40 subjects with a BMI range of 21 to 47, demonstrated that the TAEUS thermo-acoustic fat fraction (TAFF) measurement closely matches the performance of MRI-PDFF, the current gold standard, at key liver fat fraction (LFF) thresholds of 12-17% and 20-22%. These thresholds are significant for clinical therapy decisions and clinical trial enrollment. The device achieved an average positive predictive value (PPV) of 100% and accuracy of 95% in the 12-17% LFF range, and a PPV of 90% and accuracy of 94% in the 20-22% range. 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The study, which included 40 subjects with a BMI range of 21 to 47, demonstrated that the TAEUS thermo-acoustic fat fraction (TAFF) measurement closely matches the performance of MRI-PDFF, the current gold standard, at key liver fat fraction (LFF) thresholds of 12-17% and 20-22%. These thresholds are significant for clinical therapy decisions and clinical trial enrollment. The device achieved an average positive predictive value (PPV) of 100% and accuracy of 95% in the 12-17% LFF range, and a PPV of 90% and accuracy of 94% in the 20-22% range. 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The study, which included 40 subjects with a BMI range of 21 to 47, demonstrated that the TAEUS thermo-acoustic fat fraction (TAFF) measurement closely matches the performance of MRI-PDFF, the current gold standard, at key liver fat fraction (LFF) thresholds of 12-17% and 20-22%. These thresholds are significant for clinical therapy decisions and clinical trial enrollment. The device achieved an average positive predictive value (PPV) of 100% and accuracy of 95% in the 12-17% LFF range, and a PPV of 90% and accuracy of 94% in the 20-22% range. ENDRA is conducting a second feasibility study in London, Ontario, Canada, expected to be completed in the coming months, and plans to engage with the FDA in 2026 regarding a pivotal study to support a De Novo submission.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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