NVCN - Neovasc shares fall after providing Tiara Transapical system update

Neovasc shares fall ([[NVCN]] -9.8%) after announcing that its Tiara Transapical system will be unable to receive a European CE mark under the current Medical Device Directive regulations.The company has been working with its Notified Body for more than a year to obtain a decision on a CE Mark for Tiara TA, including an ongoing exchange of additional information beyond the original submission. Neovasc has determined that it will be unable to provide the additional information required by the Notified Body, which includes further testing data, before the current MDD regulations end next month.

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Neovasc shares fall after providing Tiara Transapical system update