Stereotaxis announced that it intends to initiate a first-in-human trial to support the CE Mark submission for its MAGiC™ catheter. Stereotaxis' MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures. The catheter's CE Mark submission was made in July 2022 and included substantial in vivo preclinical, lab and bench data.

The submission strategy was in-line with multiple historical precedents for similar ablation catheters as well as verbal feedback provided by the European Notified Body. Given evolving interpretation of recent EU Medical Device Regulation, the Notified Body has now requested clinical data to support the submission. Stereotaxis intends to complete a first-in-human study to support the MAGiC submission before the end of this year.