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CE mark

This page shows the latest CE mark news and features for those working in and with pharma, biotech and healthcare.

FDA okays Roche’s COVID-19 diagnostic test

FDA okays Roche’s COVID-19 diagnostic test

Roche said a CE-IVD test is also available in markets accepting the CE mark, for patients with symptoms of COVID-19 in affected areas. ... CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to

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  • Changes to look out for in Medical Devices Regulations Changes to look out for in Medical Devices Regulations

    PIP. In 2000, it was discovered that Poly Implant Prothèse (PIP) had been using industrial-grade silicone instead of the medical-grade specified for the CE mark in the manufacture of ... The CE mark for PIP implants was consequently withdrawn, and

  • Deal Watch June 2016 Deal Watch June 2016

    In Europe Cerus expects to apply for a CE Mark for the Intercept RBC System in the second half of 2016.

  • Pharma deals during November 2012 Pharma deals during November 2012

    The V2 is one of 5 hypertension-treating devices with a CE mark and will compete with Medtronic's “Symplicity” (acquired from Ardian for $800m) and Covidien's “OneShot” (acquired from

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