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June 3, 2021

Access to De Novo Summaries – A treasure for manufacturers

The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices for which there are no legally marketed predicate devic...

June 3, 2021

De Novo paving the path for Technological Advancements

While there existed many computerized and digital tomographs with specific applications (Trauma CT, Cardiac CT, CT used in Nuclear Medicine / PET), there has never been one with an application i...

June 3, 2021

De Novo – A Propeller for Innovation!

While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never do they want to decelerate the pace at which new techno...