CarnaLife Holo with FDA (Food and Drugs Administration) certification for the US market!
We are proud to announce that our CarnaLile Holo technology for augmented reality imaging of medical data (interactive holograms) has received 510(k) Class II certification for the world’s largest and richest market for new technology and robotic technology.
We have reached another milestone in MedApp’s development. The FDA certification gives us the opportunity to talk on a par with the world’s largest medical-technology companies. It is worth mentioning that the 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 that meets the highest clinical standards.
We are among the few Polish companies that have so far earned FDA certification. This puts us at the forefront of medtech solutions from Poland. The FDA certificate 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 selling our technology. – says Krzysztof Mędrala CEO of MedApp S.A.
CarnaLife Holo’s 510 (k) certification covers the planning and support of medical procedures.
It gives us the potential, to offer CLH to leading medical equipment manufacturers in the US, as well as directly to hospitals.
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