secwatch.observer — SEC 8-K summary
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Issuer:     Spectral AI, Inc. (MDAI)
CIK:        0001833498
Form:       8-K
Filed at:   2025-06-30T23:59:59+00:00
Accession:  0001213900-25-059623
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Spectral AI submits De Novo request to FDA for DeepView burn assessment system
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- Spectral AI submitted a De Novo request to the FDA for its DeepView System on June 30, 2025.
- DeepView System uses multispectral imaging and AI to assess burn wound healing potential within 7 days of injury.
- Due to novel technology with no predicate device, the De Novo regulatory pathway is being pursued.
- System trained on over 340 billion clinically validated data points to provide non-healing prediction.
- DeepView received Breakthrough Device Designation from FDA in 2018.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1833498/000121390025059623/0001213900-25-059623-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1833498/000121390025059623/ea0247532-8k_spectral.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-059623

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