secwatch.observer — SEC 8-K summary
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Issuer:     ENDRA Life Sciences Inc. (NDRA)
CIK:        0001681682
Form:       8-K
Filed at:   2024-05-20T23:59:59+00:00
Accession:  0001654954-24-006635
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1681682/000165495424006635/0001654954-24-006635-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1681682/000165495424006635/ndra_8k.htm
  HTML page:      https://secwatch.observer/filing/0001654954-24-006635

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer