Regulatory: Page 25

Elekta wins CE Mark for radiation therapy couchtop

By AuntMinnieEurope.com staff writers

Radiation oncology firm Elekta has received the CE Mark for its new modular couchtop for radiation therapy, the company said.

March 27, 2012

European Commission launches CE Mark site

By AuntMinnieEurope.com staff writers

The European Commission has launched a CE Mark website, which is available in 24 languages.

March 18, 2012

Dutch extend warning on French breast implants

By Reuters Health

AMSTERDAM (Reuters) - Dutch authorities on Thursday warned thousands of women who had breast implants made by French company Poly Implant Prothese before 2001 to consider removing them because they may leak silicone that could harm their health.

March 15, 2012

Mevion gets CE Mark for proton therapy system

By AuntMinnieEurope.com staff writers

Radiation therapy company Mevion Medical Systems has received CE Mark approval for its Mevion S250 proton therapy system.

March 13, 2012

Medtronic gets CE Mark for MRI pacing leads

By AuntMinnieEurope.com staff writers

Interventional technology firm Medtronic has obtained CE Mark approval for its CapSure Sense MRI SureScan pacing leads.

March 4, 2012

Koning receives CE Mark for 3D breast CT

By AuntMinnieEurope.com staff writers

Koning has obtained CE Mark approval for its Koning Breast CT system.

February 27, 2012

BIR sponsors medicolegal conference

By AuntMinnieEurope.com staff writers

The British Institute of Radiology (BIR) is sponsoring a daylong medicolegal conference for radiologists on 22 March at its headquarters in London.

February 14, 2012

In PIP implant scandal, a ragged safety net exposed

By Reuters Health

LONDON (Reuters) - In June 2000, when American medical regulators posted a warning letter on the Internet about problems at a breast-implant maker in southern France, French authorities didn't pay much attention.

February 2, 2012

Navidea seeks to market Lymphoseek in Europe

By AuntMinnieEurope.com staff writers

Radiopharmaceutical developer Navidea Biopharmaceuticals intends to file a marketing authorization application in Europe for Lymphoseek, a kit for the preparation of technetium Tc 99m for injection, the company said.

February 2, 2012

French breast implant boss arrested

By Reuters Health

MARSEILLE, France (Reuters) - Jean-Claude Mas, the Frenchman who has sparked a global health scare by selling substandard breast implants, was arrested on Thursday and could be charged with manslaughter, the public prosecutor in the city of Marseille said.

January 25, 2012

Europe puts MRI rules on hold for 2 more years

By Leo Cendrowicz

BRUSSELS - The planned reform of the European Union's MRI regulations has been postponed for another two years after officials conceded this week that they would not be able to wrap up the legislative process by the end-of-April deadline.

January 25, 2012

Digirad obtains CE Mark for Cardius

By AuntMinnieEurope.com staff writers

Nuclear medicine firm Digirad has received the CE Mark for its Cardius X-ACT imaging system in Europe.

January 25, 2012

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