DeNovo

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de-novo-summaries
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 devices. It is one of the least used pathways by medical device manufacturers when bringing a product to market because of the associated data requirements,…

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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 in the respiratory space. Electrical impedance tomography (EIT) is a noninvasive, non-radiologic imaging modality that is useful for the assessment of lung disorders during mechanical…

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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 technologies are coming to the market. Along these lines is the FDA’s De Novo classification process which is used to classify medical devices…

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