secwatch.observer — SEC 8-K summary
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Issuer:     Stereotaxis, Inc. (STXS)
CIK:        0001289340
Form:       8-K
Filed at:   2023-06-15T23:59:59+00:00
Accession:  0001493152-23-021433
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Stereotaxis to initiate first-in-human trial for MAGiC catheter after CE Mark clinical data request
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- Notified body requests clinical data for MAGiC catheter CE Mark under EU MDR; prior submission included preclinical data.
- First-in-human trial to commence to support CE Mark; Stereotaxis expects to complete study before end of 2023.
- Company reiterates expectation of double-digit revenue growth in 2023; strong cash position.
- CEO states innovation strategy includes accessible robot and proprietary catheters for EP and endovascular interventions.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1289340/000149315223021433/0001493152-23-021433-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1289340/000149315223021433/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-021433

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