Regulatory: Page 26

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
Spain health service chokes as austerity tightens
By Reuters Health
MADRID (Reuters) - Medical suppliers haven't been paid for as much as two years, emergency rooms have been shut down, and doctors in Catalonia have been told to accept a pay cut or 1,500 medical residents will lose their jobs.
October 10, 2011
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Avinger obtains CE Mark for catheter
By AuntMinnieEurope.com staff writers
Cardiology catheter manufacturer Avinger has received CE Mark approval for its Ocelot catheter.
September 27, 2011
FDA offers guidance to device importers
By AuntMinnieEurope.com staff writers
The U.S. Food and Drug Administration has published a new document that offers guidance to companies importing electronic devices into the U.S. that emit radiation.
September 8, 2011
Naviscan's PEM gets CE Mark
By AuntMinnieEurope.com staff writers
PET developer Naviscan has received the CE Mark for both its high-resolution positron emission mammography (PEM) scanner and PET-guided biopsy accessory.
September 7, 2011
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