Regulatory: Page 13

Alpinion nets CE Mark for HIFU system
By AuntMinnieEurope.com staff writers
Korean ultrasound technology developer Alpinion Medical Systems has received the CE Mark for its Alpius 900 ultrasound-guided high intensity focused ultrasound (HIFU) system for the treatment of uterine fibroids.
February 16, 2016
Fuji VisualSonics gets CE Mark for Vevo MD
By AuntMinnieEurope.com staff writers
Ultrasound developer Fujifilm VisualSonics has received the CE Mark for its Vevo MD ultrahigh-frequency clinical ultrasound system.
January 10, 2016
Varian gets Saudi OK for proton therapy system
By AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received clearance from the Saudi Food and Drug Authority (FDA) to market its ProBeam proton therapy system.
January 10, 2016
European Commission to draft new cybersecurity law
By AuntMinnieEurope.com staff writers
The European Commission has announced it will draft new legislation requiring healthcare providers to take stronger security measures and report breaches to the authorities.
December 8, 2015
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
Previous Page
Page 13 of 34
Next Page