---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-021433"
form_type: "8-K"
ticker: "STXS"
cik: "0001289340"
company_name: "Stereotaxis, Inc."
filed_at: "2023-06-15T23:59:59+00:00"
generated_at: "2026-06-13T23:48:27.340965+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Stereotaxis to initiate first-in-human trial for MAGiC catheter after CE Mark clinical data request

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-23-021433
- form_type: 8-K
- ticker: STXS
- cik: 0001289340
- company_name: Stereotaxis, Inc.
- filed_at: 2023-06-15T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1289340/000149315223021433/0001493152-23-021433-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1289340/000149315223021433/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-021433
- JSON: https://secwatch.observer/filing/0001493152-23-021433.json
- Plain text: https://secwatch.observer/filing/0001493152-23-021433.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.