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FDA approval
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SentiAR announces FDA clearance for CommandEP interface on Magic Leap 2
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Oct 12, 2023
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Extended Reality

Extended Reality

Oct 12, 2023

SentiAR announces FDA clearance for CommandEP interface on Magic Leap 2

FDA approval
Partnerships

  • SentiAR, in collaboration with Magic Leap, announced that its CommandEP interface received a second FDA 510K clearance. This interface is integrated with Magic Leap 2 and is the first application of its kind globally.

  • SentiAR's CommandEP merges existing 3D cardiac mapping systems to produce a real-time 3D holographic interface. This provides physicians with an interactive, 360-degree view of a patient's specific heart anatomy, enabling them to administer cardiac ablation therapy with increased precision. 

  • The system, available on Magic Leap 2, can be worn by doctors, offering hands-free manipulation of patient data, including real-time heart anatomy and catheter positions within the heart. This advancement grants physicians enhanced control over their digital tools during cardiac ablation procedures. SentiAR plans to finalize new clinical studies in the latter half of this year.

  • Analyst QuickTake: SentiAR initially received FDA clearance for its CommandEP platform, accessible via Microsoft’s HoloLens headset in September 2020 , making it the first holographic guidance system to be used during an invasive cardiac procedure. The launch of the platform on the Magic Leap 2 will further democratize access to its HealthTech solutions, with the company having raised USD 8.5 million to expand clinical deployments of its platform in April 2023 .

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