Regulatory: Page 24

Eucomed, EDMA appoint new chief executive

By AuntMinnieEurope.com staff writers

The European medical technology industry association Eucomed and the European Diagnostic Manufacturers Association (EDMA) have appointed Serge Bernasconi as chief executive for both organizations.

July 8, 2012

Brussels gets ready to implement new radiation protection rules

By Leo Cendrowicz

A European Union directive looks set to impose new risk levels for ionizing radiation as part of an effort to lay down basic safety standards for protection against exposure. The proposed measure consolidates five separate pieces of existing legislation into a single directive.

June 24, 2012

Ultrasonix's SonixGPS gets CE mark

By AuntMinnieEurope.com staff writers

Ultrasound vendor Ultrasonix Medical has received CE certification for its SonixGPS technology for regional anesthesia and vascular access, making it available throughout the EU.

June 6, 2012

NinePoint receives CE Mark

By AuntMinnieEurope.com staff writers

Optical coherence tomography developer NinePoint Medical has received European CE Mark approval for its NvisionVLE imaging system, the company said.

June 5, 2012

IsoRay receives CE Mark for GliaSite

By AuntMinnieEurope.com staff writers

Medical isotope developer IsoRay has received the European CE Mark for its GliaSite radiation therapy system.

May 22, 2012

TomTec gets FDA nod for cardiac MR software

By AuntMinnieEurope.com staff writers

Imaging software developer TomTec Imaging Systems has received 501(k) clearance from the U.S. Food and Drug Administration for its new 2D Cardiac Performance Analysis MR software.

April 22, 2012

European Commission causes yet more chaos over MRI

By Dr. Peter Rinck, PhD

The new European Union directive on magnetic resonance is an eye-opener. It shows how estranged politicians and civil servants are from daily life. It would help close down all MR facilities in the EU because nobody would be allowed to work close to an MR system.

April 15, 2012

Elekta wins CE Mark for collimator

By AuntMinnieEurope.com staff writers

Radiation oncology firm Elekta has received the CE Mark for its new multileaf collimator, Agility.

April 1, 2012

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

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