regulatory
confidence high
sentiment neutral
materiality 0.65
Stereotaxis to initiate first-in-human trial for MAGiC catheter after CE Mark clinical data request
Stereotaxis, Inc.
- 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.