secwatch.observer — SEC 8-K summary
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Issuer:     DAXOR CORP (DXR)
CIK:        0000027367
Form:       8-K
Filed at:   2024-01-02T23:59:59+00:00
Accession:  0001493152-24-000035
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Daxor submits next-gen BVA to FDA for 510(k)/CLIA-waiver; clearance expected H1 2024
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- Submission via dual 510(k)/CLIA-waiver pathway to FDA for next-generation blood volume analyzer.
- New device designed to be three times faster, simpler, portable, and capable of bedside analysis.
- Development funded under contract by U.S. Department of Defense.
- Potential FDA clearance is expected during the first half of 2024.
- Current BVA-100 is only FDA-cleared diagnostic for direct blood volume measurement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/27367/000149315224000035/0001493152-24-000035-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/27367/000149315224000035/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-000035

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