---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-24-006635"
form_type: "8-K"
ticker: "NDRA"
cik: "0001681682"
company_name: "ENDRA Life Sciences Inc."
filed_at: "2024-05-20T23:59:59+00:00"
generated_at: "2026-06-01T12:54:34.208589+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# ENDRA Life Sciences completes FDA pre-submission meeting for TAEUS liver device

## Summary
- In-person FDA pre-sub meeting held May 16, 2024, on TAEUS liver device clinical trial design for de novo submission.
- FDA feedback deemed highly constructive; ENDRA to update pivotal study protocol and statistical plan.
- Company expects to complete clinical studies by Q4 2024 or Q1 2025, with de novo filing in first half 2025.
- Provided background data from 45 historical participants; demonstrated TAEUS procedure with liver phantoms.

## SEC filing metadata
- accession: 0001654954-24-006635
- form_type: 8-K
- ticker: NDRA
- cik: 0001681682
- company_name: ENDRA Life Sciences Inc.
- filed_at: 2024-05-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1681682/000165495424006635/0001654954-24-006635-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1681682/000165495424006635/ndra_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-24-006635
- JSON: https://secwatch.observer/filing/0001654954-24-006635.json
- Plain text: https://secwatch.observer/filing/0001654954-24-006635.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.