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Medical Devices / Submissions and Approvals

Medivis Wins FDA Clearance for Augmented Reality Surgical System

June 3, 2019
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The FDA granted New York City-based Medivis 510(k) clearance for its SurgicalAR augmented reality technology platform for clinical use in the operating room. The platform uses holographic visualization to help reduce surgical complications.

“The surgical world continues to primarily rely on two-dimensional imaging technology to understand and operate on incredibly complex patient pathology,” says Medivis co-founder and CEO Osamah Choudhry. He calls holographic visualization “the final frontier of surgical imaging and navigation.”

The company will begin commercialization of the platform in the United States immediately.

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