Regulatory: Page 26

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
2012 01 09 10 47 27 752 2012 01 09 Reuters Implants Thumb
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
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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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Italy orders list of women with French firm's implants
By Reuters Health
ROME (Reuters) - Italy will tell hospitals and clinics to compile a list of women who received breast implants from a French firm accused of selling faulty prosthetics, Health Minister Renato Balduzzi said Thursday.
December 29, 2011
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SonoSite's Edge scanner gets CE Mark
By AuntMinnieEurope.com staff writers
Compact-ultrasound developer SonoSite announced that it has received the CE Mark for its new Edge point-of-care ultrasound scanner, which is now available for immediate shipment in the European Union.
December 21, 2011
French breast implant fears spread around world
By Reuters Health
LONDON/PARIS (Reuters) - Fears over the safety of silicone breast implants made by a now defunct French firm spread to Australia, South America, and across Europe on Thursday as French officials prepared to decide if thousands of women should have their implants surgically removed.
December 21, 2011
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Philips gets FDA clearance for PET/MRI
By AuntMinnieEurope.com staff writers
Royal Philips Electronics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its whole-body Ingenuity PET/MRI system
November 27, 2011
Vascular Designs gets CE Mark for infusion catheter
By AuntMinnieEurope.com staff writers
Infusion catheter manufacturer Vascular Designs has received CE Mark approval for its IsoFlow infusion catheter.
November 14, 2011
MRI reception in Brussels to discuss EU directive
By AuntMinnieEurope.com staff writers
The Alliance for MRI will hold a reception at the European Parliament in Brussels on 8 November.
November 2, 2011
OctreoPharm gets orphan drug approval
By AuntMinnieEurope.com staff writers
German nuclear medicine contrast company OctreoPharm Sciences has obtained orphan drug status for its SOMscan contrast agent for diagnosis of gastro-entero-pancreatic neuroendocrine tumors from the European Medicines Agency.
October 12, 2011
COCIR supports software harmonization
By AuntMinnieEurope.com staff writers
As pressure grows to harmonize global approaches for regulating medical software, representatives of leading European standards organizations and industry trade associations have met in Brussels to discuss the benefits of aligning standards with regulations on medical software.
October 11, 2011
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