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Biocartis devices exempt from US FDA 510(k) notification requirements.

M2 PHARMA-July 12, 2017-Biocartis devices exempt from US FDA 510(k) notification requirements

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Belgium-based molecular diagnostics specialist Biocartis Group NV (EBR: BCART) reported on Wednesday that its Idylla Instrument and Idylla Console are on the final list of devices that are exempted from 510(k) premarket notification requirements in accordance with the US 21st Century Cures Act.

The product code related to the Biocartis Idylla Instrument and Idylla Console is included on this list. As a result, Biocartis' Idylla Instrument and Idylla Console will no longer be subject to the 510(k) notification requirements.

Vishal Sikri, general manager of Biocartis US, commented: "The publication of this list by the US FDA will allow us to speed up the introduction of our fully automated Idylla platform in the US.

"This positive news is one more step towards our vision of bringing high value, rapid molecular diagnostic testing to hospitals in the US."

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Publication:M2 Pharma
Date:Jul 12, 2017
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