FDA Gives Second 510K Clearance to SentiAR’s CommnandEP Interface

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Device adds new integration.

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SentiAR, Inc., a company focused on augmented reality (AR) visualization technology for medical procedures, revealed that it has received a second 510k approval for the CommandEP, adding a new integration. According to a company press release, the device 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.

"We are excited to have gained our second 510K clearance for our innovative CommandEP technology with a new integration,” said Berk Tas, CEO, SentiAR, in the aforementioned release. “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."

Reference: SentiAR Announces Second FDA Clearance for CommandEP™ Interface. PR Newswire. October 12, 2023. Accessed October 16, 2023. https://www.prnewswire.com/news-releases/sentiar-announces-second-fda-clearance-for-commandep-interface-301954530.html

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