SentiAR Announces Second FDA Clearance for CommandEP Interface Utilizing Magic Leap 2 Platform

Earlier this year, Magic Leap announced that Magic Leap 2 received certification as an IEC 60601 certified component, a technical standard for the electrical safety of medical electrical equipment that allows Magic Leap 2 to be used or incorporated into a medical device for use in an operating room and other clinical settings.

Today, Magic Leap partner, SentiAR, announced it has received a second FDA 510K clearance with CommandEP™ adding a new integration. CommandEP is the first application of its kind in the world.

SentiAR’s 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 is available on Magic Leap 2 which allows it to be 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.

SentiAR anticipates completion of new clinical studies in the second half of this year.