SentiAR Announces Second FDA Clearance for CommandEPtm Interface

Continued expansion of clinical and industry partnerships

ST. LOUIS, Oct. 12, 2023 /PRNewswire/ -- SentiAR, Inc. a St. Louis, Missouri based pioneer in using Augmented Reality (AR) visualization technology for medical procedures has received their second FDA 510K clearance CommandEPtm adding a new integration.

CommandEPtm 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.

Berk Tas, CEO of SentiAR said, "We are excited to have gained our second 510K clearance for our innovative CommandEPtm technology with a new integration. 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." 

Gregory Michaud, MD, Clinical Director, Telemachus & Irene Demoulas Family Foundation Center for Cardiac Arrhythmias at Massachusetts General Hospital said "Our initial clinical experience with the CommandEP system has been promising. Being able to see patient anatomy in full 3D visualization with contact force allows us to identify targets and navigate more efficiently. We look forward to continuing our use of the system as new features are developed."

CommandEP is the first application of its kind in the world and SentiAR anticipates completion of new clinical studies later this year.

About SentiAR:

SentiAR, Inc., based in St. Louis, MO, was founded by Dr. Jennifer Silva, MD, FHRS, FACC, FAHA, Dr. Jonathan Silva, PhD of Washington University in St Louis and Mike Southworth, MS. SentiAR received an SBIR award from NIH alongside support from BioGenerator and Cultivation Capital to start its journey alongside support from cultivate(MD), TechWald Holdings, Medventure Partners, Cultivation Capital Biogenerator and Harmonix.  Following the founding team's vision SentiAR has created the first application of Mixed Reality technology for use during interventional procedures, starting with cardiac ablation procedures, including the treatment of atrial fibrillation.  The SentiAR platform provides an immersive command center for the clinicians by presenting a 3D hologram of the patient's electro-anatomic data in real-time.  This solution gives the clinician unprecedented control via SentiAR's patent-protected, intuitive gaze interface and provides invaluable insight to guide physician diagnosis and catheter navigation.  Learn more about SentiAR at https://sentiar.com.

SOURCE SentiAR