CarnaLife Holo – MedApp's technology for augmented reality imaging of medical data – has received FDA 510(k) Class II clearance, opening the way to the largest medical market in the world.
We are proud to announce that our CarnaLife Holo technology for augmented reality imaging of medical data (interactive holograms) has received 510(k) Class II clearance for the world's largest and richest market for new and robotic technologies.
We have reached another milestone in MedApp's development. FDA clearance gives us the opportunity to talk on a par with the world's largest medical technology companies. It is worth noting that certification of medical devices and technologies for the US market is one of the most rigorous in the world, which reassures us, doctors and investors that the solution offered by MedApp is a mature, fully validated product meeting the highest clinical standards.
We are among the few Polish companies to have earned FDA clearance so far. This puts us at the forefront of medtech solutions from Poland. FDA clearance opens the way for us to enter the largest medical market in the world, and the United States should eventually become one of the main markets for our technology.
CarnaLife Holo's 510(k) clearance covers the planning and support of medical procedures. This gives us the potential to offer CarnaLife Holo to leading medical equipment manufacturers in the US as well as directly to hospitals.
More about CarnaLife HoloThe latest on MedApp, CarnaLife Holo and our deployments.
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