Regulatory: Page 25

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

Planmed receives CE Mark for Verity

By AuntMinnieEurope.com staff writers

Medical imaging vendor Planmed announced it has received the CE Mark for its Verity mobile extremity conebeam CT scanner.

January 24, 2012

EU medicines head urges tougher implant rules

By Reuters Health

LONDON (Reuters) - The new head of Europe's drugs watchdog said on Friday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of a global scandal over French-made breast implants.

January 8, 2012

Czechs say women should replace PIP implants

By Reuters Health

PRAGUE (Reuters) - Czech women with silicone breast implants manufactured by a French firm accused of using unapproved industrial-grade material should have them replaced, a Health Ministry spokesman said on Thursday.

January 5, 2012

U.K. wants results of breast implant review this week

By Reuters Health

LONDON (Reuters) - Britain expects the results of a review of breast implant safety to come this week following a global health scare focused on products from a now defunct French company, Health Secretary Andrew Lansley said on Wednesday.

January 3, 2012

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