Regulatory: Page 13

Densitas receives CE Mark, Canadian clearance
By AuntMinnieEurope.com staff writers
Medical device firm Densitas has received the CE Mark from the European Commission and a medical device license from Health Canada for its DM-Density breast density assessment software.
November 30, 2015
FDA clears new Visus software update
By AuntMinnieEurope.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared version 4.7 of the JiveX software from PACS firm Visus.
November 16, 2015
Lightpoint gets CE Mark for molecular imaging device
By AuntMinnieEurope.com staff writers
Luminescence imaging technology developer Lightpoint Medical has obtained CE Mark approval for its LightPath imaging system, an intraoperative molecular imaging device.
October 19, 2015
Varian gets CE Mark for proton therapy system
By AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received a CE Mark for its latest ProBeam proton therapy system.
October 12, 2015
Gamma Medica receives CE Mark for breast system
By AuntMinnieEurope.com staff writers
Gamma Medica has received a CE Mark for the sale and distribution of its LumaGem molecular breast imaging (MBI) system within the European economic area.
October 12, 2015
Varian gets regulatory clearance for VitalBeam
By AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration and the European CE Mark for its VitalBeam radiation therapy system.
October 6, 2015
COCIR has wish list for new Medical Devices Regulation
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) said it hopes the final Medical Devices Regulation (MDR) will capitalize on the current regulatory framework and be robust, transparent, and open to innovation.
October 6, 2015
Fuji SonoSite secures CE Mark for iViz platform
By AuntMinnieEurope.com staff writers
Ultrasound developer Fujifilm SonoSite has received the European CE Mark for iViz, a new ultrasound platform designed for point-of-care settings.
September 20, 2015
Boston Scientific gets CE Mark for MRI-ready defibrillators
By AuntMinnieEurope.com staff writers
Interventional and ultrasound technology developer Boston Scientific has received the CE Mark for MRI-conditional labeling for cardioverter defibrillators.
August 24, 2015
St. Jude obtains CE Mark for MRI chronic pain unit
By AuntMinnieEurope.com staff writers
St. Jude Medical has received the CE Mark for MRI-conditional labeling for its Prodigy MRI chronic pain unit with select leads.
August 23, 2015
The King's Fund promotes NHS savings
By AuntMinnieEurope.com staff writers
The King's Fund is advocating the U.K.'s National Health Service (NHS) save 22 billion pounds (28 billion euros) by 2020-2021 in its new report.
July 14, 2015
DITTA advocates revision in U.N. development plan
By AuntMinnieEurope.com staff writers
The Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA) wants the word "technologies" in the Sustainable Development Goal (SDG) 3, Target 3B.
July 14, 2015
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