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Home » SentiAR Secures 510(K) Clearance for Holographic Cardiac System

SentiAR Secures 510(K) Clearance for Holographic Cardiac System

October 2, 2020

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.

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