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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.

Roche launches two antibodies to identify mutation status in brain cancer patients

Both tests are now available in the US, Roche said, and will likely be made accessible in other non-CE markets later this year and in 2024 for countries that accept ... the CE mark.

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Biogen and Alcyone Therapeutics partner in deal worth over $50m

ThecaFlex, an implantable medical device intended for subcutaneous delivery of ASO therapies into the intrathecal space, has already received a CE Mark in Europe and Breakthrough Device Designation from the US
Roche announces launch of HPV self-sampling solution for cervical cancer screening

Roche has announced the launch of a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark, expanding access to HPV screening options by enabling patients to privately collect
Healthineers’ COVID-19 antibody test launches in EU

Healthineers announced today that the sCOVG test has now achieved a CE mark, meaning that it can be marketed in the EU.
Roche plans to launch rapid COVID-19 antigen test later this month

Swiss pharma company Roche has plans to launch its rapid SARS-CoV-2 antigen test in late September for markets accepting the CE mark in the EU.
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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The future of medtech is in the past

CE mark on medical devices sold in Northern Ireland and the EU.
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 The CE mark for PIP implants was consequently withdrawn, and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

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

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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