We are proud to announce that KERASAVE, the completely synthetic with antifungal media by Alchimia, intended for corneal storage at 4°C for up to 14 days, has obtained the De Novo granting by the US government agency Food and Drug Administration (FDA).
A great result was achieved by the Alchimia team, built by constant investments in research and development in a sector, such as eye banking, that requests high-performance medical devices, capable of ensuring safety and maximum effectiveness.
Now, when more than 12 million people in the world are awaiting corneal transplant surgeries, FDA authorizes the use of KERASAVE, one of the most comprehensive and innovative products on the market.
THE FDA DECISION
FDA – US Food and Drug Administration has identified KERASAVE as a corneal storage medium with preservatives including antifungals.
As a Class II medical device subject to prescription, KERASAVE will be used to temporarily preserve human cornea tissue between harvesting and implantation.
As a result of this order, KERASAVE is becoming immediately available for use in the USA.
WHAT DOES IT MEAN TO HAVE BEEN GRANTED A DE NOVO CLASSIFICATION FROM THE FDA?
Having registered a medical device according to a De Novo means being the pioneer of a new category of products never existed before.
All those who want to register similar medical device will have to prove to the FDA that the device has the same performance and safety features as KERASAVE, which becomes the reference standard for its category.
Watch the video and learn how to use KERASAVE
The result of the De Novo registration of KERASAVE is available directly on the FDA website
https://www.fda.gov/about-fda/cdrh-transparency/evaluation-automatic-class-iii-designation-de-novo-summaries
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