secwatch.observer — SEC 8-K summary
======================================

Issuer:     Cytosorbents Corp (CTSO)
CIK:        0001175151
Form:       8-K
Filed at:   2025-08-20T23:59:59+00:00
Accession:  0001104659-25-080908
Event type: regulatory
Sentiment:  neutral
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA upholds DrugSorb-ATR De Novo denial but offers path forward
---------------------------------------------------------------

- FDA appeal decision found no safety issues with DrugSorb-ATR but upheld the prior De Novo denial.
- FDA proposed a potential path to market authorization; Company discussing details with the Agency.
- Another appeal avenue with CDRH Director is available within 30 days; Company evaluating.
- CEO states resolution of majority of outstanding issues; device remains an FDA Breakthrough Device.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1175151/000110465925080908/0001104659-25-080908-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1175151/000110465925080908/tm2523975d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-080908

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