ENDRA Life Sciences (NDRA) FDA Approvals $4.73 -0.31 (-6.15%) Closing price 04:00 PM EasternExtended Trading$4.70 -0.03 (-0.53%) As of 07:40 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock ENDRA Life Sciences' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by ENDRA Life Sciences (NDRA). Over the past two years, ENDRA Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TAEUS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. TAEUS FDA Regulatory Events TAEUS is a drug developed by ENDRA Life Sciences for the following indication: Device. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Results - December 4,2025Results Drug: TAEUSAnnounced Date: December 4, 2025Indication: DeviceAnnouncementENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.AI SummaryENDRA Life Sciences reported 2025 feasibility study results showing its TAEUS device’s thermo-acoustic fat fraction (TAFF) measurement closely matches MRI-PDFF at key liver fat fraction (LFF) decision points. In 40 subjects (BMI 21–47), TAEUS performed strongly at the 12–17% range (grade 1–2 steatosis) with average PPV 100%, NPV 94% and accuracy 95%. At the 20–22% range (grade 2–3 steatosis) it showed average PPV 90%, NPV 94% and accuracy 94%. These thresholds are used to decide treatment, reimbursement, and trial inclusion. High PPV means TAEUS can reliably identify patients above treatment cutoffs; high NPV helps rule out those below them. Because TAEUS is designed as a low‑cost, point‑of‑care option (targeted cost under $200), these results support its potential to reduce reliance on expensive MRI‑PDFF exams and enable more frequent, practical monitoring during drug development and clinical care.Read AnnouncementResults - December 4,2025Results Drug: TAEUSAnnounced Date: December 4, 2025Indication: DeviceAnnouncementENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.AI SummaryENDRA Life Sciences reported 2025 feasibility results showing its TAEUS device’s thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI‑PDFF gold standard at key liver fat fraction (LFF) thresholds used for clinical decisions. In a 40‑subject study (BMI 21–47), TAEUS matched MRI‑PDFF performance in the critical 12–17% and 20–22% LFF ranges that separate mild, moderate and severe steatosis. Performance at those cutoffs was strong: for 12–17% LFF, average PPV was 100%, NPV 94%, and accuracy 95%; for 20–22% LFF, average PPV was 90%, NPV 94%, and accuracy 94%. High PPV supports identifying patients above treatment or trial thresholds, while high NPV helps rule out those below. ENDRA positions TAEUS as a lower‑cost, point‑of‑care alternative to MRI‑PDFF for patient stratification and frequent trial monitoring, potentially reducing screening and monitoring costs and enabling more accessible longitudinal liver fat measurement.Read AnnouncementPreliminary Results - November 20,2025Preliminary Results Drug: TAEUSAnnounced Date: November 20, 2025Indication: DeviceAnnouncementENDRA Life Sciences Inc. announces encouraging preliminary results from a single-site clinical feasibility study evaluating its improved TAEUS Liver device for quantifying liver fat fraction, which is a key biomarker of steatotic liver disease ("SLD").Read Announcement ENDRA Life Sciences FDA Events - Frequently Asked Questions Has ENDRA Life Sciences received FDA approval? As of now, ENDRA Life Sciences (NDRA) has not received any FDA approvals for its therapy in the last two years. What drugs has ENDRA Life Sciences submitted to the FDA? In the past two years, ENDRA Life Sciences (NDRA) has reported FDA regulatory activity for TAEUS. What is the most recent FDA event for ENDRA Life Sciences? The most recent FDA-related event for ENDRA Life Sciences occurred on December 4, 2025, involving TAEUS. The update was categorized as "Results," with the company reporting: "ENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%." What conditions do ENDRA Life Sciences' current drugs treat? Currently, ENDRA Life Sciences has one therapy (TAEUS) targeting the following condition: Device. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Inspira Technologies OXY B.H.N. 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Results - December 4,2025Results Drug: TAEUSAnnounced Date: December 4, 2025Indication: DeviceAnnouncementENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.AI SummaryENDRA Life Sciences reported 2025 feasibility study results showing its TAEUS device’s thermo-acoustic fat fraction (TAFF) measurement closely matches MRI-PDFF at key liver fat fraction (LFF) decision points. In 40 subjects (BMI 21–47), TAEUS performed strongly at the 12–17% range (grade 1–2 steatosis) with average PPV 100%, NPV 94% and accuracy 95%. At the 20–22% range (grade 2–3 steatosis) it showed average PPV 90%, NPV 94% and accuracy 94%. These thresholds are used to decide treatment, reimbursement, and trial inclusion. High PPV means TAEUS can reliably identify patients above treatment cutoffs; high NPV helps rule out those below them. Because TAEUS is designed as a low‑cost, point‑of‑care option (targeted cost under $200), these results support its potential to reduce reliance on expensive MRI‑PDFF exams and enable more frequent, practical monitoring during drug development and clinical care.Read Announcement
Results - December 4,2025Results Drug: TAEUSAnnounced Date: December 4, 2025Indication: DeviceAnnouncementENDRA Life Sciences Inc announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%.AI SummaryENDRA Life Sciences reported 2025 feasibility results showing its TAEUS device’s thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI‑PDFF gold standard at key liver fat fraction (LFF) thresholds used for clinical decisions. In a 40‑subject study (BMI 21–47), TAEUS matched MRI‑PDFF performance in the critical 12–17% and 20–22% LFF ranges that separate mild, moderate and severe steatosis. Performance at those cutoffs was strong: for 12–17% LFF, average PPV was 100%, NPV 94%, and accuracy 95%; for 20–22% LFF, average PPV was 90%, NPV 94%, and accuracy 94%. High PPV supports identifying patients above treatment or trial thresholds, while high NPV helps rule out those below. ENDRA positions TAEUS as a lower‑cost, point‑of‑care alternative to MRI‑PDFF for patient stratification and frequent trial monitoring, potentially reducing screening and monitoring costs and enabling more accessible longitudinal liver fat measurement.Read Announcement
Preliminary Results - November 20,2025Preliminary Results Drug: TAEUSAnnounced Date: November 20, 2025Indication: DeviceAnnouncementENDRA Life Sciences Inc. announces encouraging preliminary results from a single-site clinical feasibility study evaluating its improved TAEUS Liver device for quantifying liver fat fraction, which is a key biomarker of steatotic liver disease ("SLD").Read Announcement
