ENDRA Life Sciences' Drug in the FDA Approval Process
This 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 Timeline and 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.
- Drug:
- TAEUS
- Announced Date:
- December 4, 2025
- Indication:
- Device
Announcement
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%.
AI Summary
ENDRA 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
- Drug:
- TAEUS
- Announced Date:
- December 4, 2025
- Indication:
- Device
Announcement
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%.
AI Summary
ENDRA 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
- Drug:
- TAEUS
- Announced Date:
- November 20, 2025
- Indication:
- Device
Announcement
ENDRA 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- Drug:
- TAEUS
- Announced Date:
- May 20, 2024
- Indication:
- Device
Announcement
ENDRA Life Sciences Inc. announced that it has completed what it considers to be a highly informative pre-submission meeting with the U.S. Food and Drug Administration (FDA) related to the clinical trial design of the TAEUS liver device in support of its U.S. De Novo filing.
AI Summary
ENDRA Life Sciences Inc. announced that it has completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for its TAEUS liver device. The meeting focused on discussing the planned pivotal clinical study, which will support ENDRA’s U.S. De Novo filing. During the meeting, the company presented a detailed description of its innovative TAEUS technology and a synopsis of the clinical study design that is both hypothesis-driven and statistically powered. ENDRA also shared background clinical data and historical statistical analyses from 45 participants to support its proposed methods. The FDA’s constructive feedback during the meeting is expected to guide the final updates to ENDRA’s clinical study protocol and statistical plan, and the company looks forward to maintaining close collaboration with the agency as it moves towards initiating the trial.
Read Announcement
ENDRA Life Sciences FDA Events - Frequently Asked Questions
As of now, ENDRA Life Sciences (NDRA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, ENDRA Life Sciences (NDRA) has reported FDA regulatory activity for TAEUS.
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%."
Currently, ENDRA Life Sciences has one therapy (TAEUS) targeting the following condition: Device.
More FDA Event Resources from MarketBeat
Companies With Recent 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
FDA progress for NASDAQ:NDRA last updated on 12/5/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
