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Home » Medivis wins FDA nod for augmented reality surgical visualization platform

Medivis wins FDA nod for augmented reality surgical visualization platform

May 31, 2019 By Fink Densford

Medivis

Surgical visualization tech dev Medivis said yesterday that it won FDA 510(k) clearance for its SurgicalAR augmented reality platform intended for clinical use in the operating room.

The New York-based company said that its SurgicalAR platform uses augmented reality, artificial intelligence and computer vision to provide improved surgical visualization in hopes of reducing surgical complications and improving patient outcomes.

“Medivis introduces advancements in holographic visualization and navigation to fundamentally advance surgical intervention, and revolutionize how surgeons safely operate on their patients. Achieving this milestone accelerates our mission to improve surgical precision and safety by allowing surgeons to see the invisible,” Medivis prez Dr. Christopher Morley said in a press release.

Medivis said that it plans to begin commercialization of the device in the U.S. immediately.

“Holographic visualization is the final frontier of surgical imaging and navigation. The surgical world continues to primarily rely on two-dimensional imaging technology to understand and operate on incredibly complex patient pathology,” Medivis CEO Dr. Osamah Choudhry said in a prepared statement.

The company also said that it recently came out of stealth mode during a $2.3 million funding round led by Initialized Capital, and that it has inked strategic partnerships with Verizon and Microsoft.

“Medical imaging for invasive surgical procedures has been waiting for a transformation like this for decades —and we knew from day one that Medivis would be the leader in this emerging space,” Initialized Capital GP Eric Woersching, said in prepared remarks.

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Regulatory/Compliance, Surgical Tagged With: Medivis

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