SentiAR Secures 510(K) Clearance for Holographic Cardiac System
St. Louis, Mo., devicemaker SentiAR has earned 510(k) clearance from the FDA for CommandEP, its holographic cardiac guidance system.
The system provides 3-D imaging during invasive cardiac procedures via a headset, showing physicians where to place catheters.
In a study, the system demonstrated a 44 percent reduction in navigation error when compared with standard visualization tools, the company said.
SentiAR aims to begin U.S. distribution of the system next year.