Regulatory: Page 19

TomTec gets FDA clearance for imaging software
By AuntMinnieEurope.com staff writers
TomTec Imaging Systems has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TomTec-Arena software.
December 2, 2013
Elekta gets FDA clearance for Monaco 5
By AuntMinnieEurope.com staff writers
Radiation oncology firm Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Monaco 5 radiation therapy treatment planning systems.
November 26, 2013
CMC lands Orphan Drug Designation by FDA
By AuntMinnieEurope.com staff writers
Swedish contrast media developer CMC Contrast has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its CMC-001 liver-specific contrast agent.
November 26, 2013
IBA secures FDA clearance for imaging software suite
By AuntMinnieEurope.com staff writers
Radiopharmaceutical provider Ion Beam Applications has received U.S. Food and Drug Administration (FDA) clearance for its adaPT Insight imaging software suite.
November 26, 2013
What should we make of the personalized medicine bandwagon?
By Dr. Peter Rinck, PhD
As the dust begins to settle on last month's summit in the European Parliament on personalized medicine, the Maverinck asks in his latest column whether the hype and optimism is truly justified.
November 17, 2013
2013 05 16 09 08 50 62 Maverinck Logo 200
EU study charts path to cost-effective cardiac imaging
By Leo Cendrowicz
BRUSSELS - Imaging has brought unprecedented insight into cardiovascular disease, but health authorities need smarter and more cost-effective screening strategies to identify high-risk patients, according to a research project presented on Thursday at a special European Parliament hearing in Brussels.
November 11, 2013
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EU committee trims medical device regulations
By AuntMinnieEurope.com staff writers
The Internal Market and Consumer Production Committee of the European Parliament on 17 October voted to exclude medical devices from the scope of the draft consumer product safety regulation.
October 20, 2013
EU pledges renewed support for personalized medicine
By Leo Cendrowicz
BRUSSELS - EU officials have vowed to work more closely with the medical imaging community to help roll out personalized medicine over the coming years. At a round-table gathering on 15 October, officials acknowledged that breakthroughs in technology presented medical opportunities too important to ignore.
October 15, 2013
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U.K. hospital group fined after radiologist exposed to radiation
By AuntMinnieEurope.com staff writers
United Lincolnshire Hospitals National Health Service Trust has been fined after an interventional radiologist was exposed to "significant" amounts of ionizing radiation.
October 7, 2013
IBA seeks FDA approval for proton therapy gantry system
By AuntMinnieEurope.com staff writers
Radiopharmaceutical firm IBA Molecular has submitted documentation to the U.S. Food and Drug Administration for a compact proton therapy gantry.
September 23, 2013
SonoSite earns CE Mark for ultrasound kiosk
By AuntMinnieEurope.com staff writers
Ultrasound developer SonoSite has received the CE Mark for its X-Porte ultrasound kiosk for point-of-care ultrasound scanning.
September 5, 2013
GE wins CE Mark for latest version of Vivid E9
By AuntMinnieEurope.com staff writers
GE Healthcare has received the CE Mark for the latest version of its Vivid E9 cardiovascular ultrasound scanner, the company said.
September 3, 2013
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