SentiAR, Inc. a St. Louis, Missouri-based provider of augmented reality (AR) visualization technology for medical procedures has received its second FDA 510(k) clearance of the CommandEP, adding a new integration.
CommandEP integrates existing 3D cardiac mapping systems to create a real time 3D holographic interface that provides physicians with an interactive, 360-degree view of the patient’s specific anatomy to allow them to deliver cardiac ablation therapy with more precision.
The CommandEP system utilizes a specially designed headset worn by the physician allowing hands-free manipulation of the patient’s data for the first time, in addition to real-time heart anatomy and catheter locations inside the heart. This technology provides physicians control of their digital tools during cardiac ablation procedures.
“We are excited to have gained our second 510(k) clearance for our innovative CommandEP technology with a new integration,” said Berk Tas, CEO of SentiAR. “This new clearance allows us to continue expanding our clinical and industry partnerships. Our physicians have been looking for a tool that can provide full 3D visualization in real-time while allowing hands-free control of images. We are honored to be able to provide this to our physicians.”
SentiAR anticipates completion of new clinical studies for the CommandEP later this year.