Regulatory: Page 220

Ampronix receives certification for clean-room facility
By AuntMinnie.com staff writers
Monitor distributor Ampronix has received certification for its new clean-room facility, the company reported.
December 26, 2007
Hitachi nets FDA OK for ProBeat feature
By AuntMinnie.com staff writers
Hitachi Medical Systems America of Twinsburg, OH, has received clearance from the U.S. Food and Drug Administration (FDA) for spot scanning irradiation technology on its ProBeat proton beam therapy system.
December 25, 2007
MediGuide Medical GPS gets CE Mark
By AuntMinnie.com staff writers
MediGuide of Haifa, Israel, has received European CE Mark certification for its Medical Position System (MPS) and MPS-enabled Guided Measurement Catheter (GMC).
December 17, 2007
BioSphere nets CE Mark OK
By AuntMinnie.com staff writers
Interventional device developer BioSphere Medical has received the European CE Mark for transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using its HepaSphere microspheres.
December 17, 2007
FDA OKs Compass dosimetry device
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Stockholm-based RaySearch Laboratories and Ion Beam Applications (IBA) of Louvain-la-Neuve, Belgium, for their jointly developed Compass dosimetry device.
December 17, 2007
Varian gets FDA OK for scanning algorithm
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems of Palo Alto, CA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new proton scanning dose algorithm.
December 13, 2007
Canadian Senate OKs Chalk River restart
By AuntMinnie.com staff writers
The Senate in Canada's Parliament last night approved legislation to restart the Chalk River nuclear reactor, which manufactures radioisotopes for nuclear medicine applications.
December 12, 2007
FDA reports RF ablation deaths
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a Public Health Notification regarding reported deaths following radiofrequency (RF) ablation of lung tumors.
December 11, 2007
Medtronic completes PMA filing for Talent
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has filed the final module of its premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its Talent abdominal stent graft system.
December 2, 2007
IDSI adds CTLM trial site
By AuntMinnie.com staff writers
CT laser mammography (CTLM) system developer Imaging Diagnostic Systems (IDSI) of Plantation, FL, has signed the 10th U.S. site to participate in its CTLM clinical trial.
November 28, 2007
Agfa gets Health Canada nod for CR mammo
By AuntMinnie.com staff writers
Agfa HealthCare of Mortsel, Belgium, has received authorization from Health Canada for the sale of its Computed Radiography (CR) Mammography system in Canada.
November 27, 2007
Alara receives FDA OK for T-Series CR system
By AuntMinnie.com staff writers
Computed radiography (CR) developer Alara announced it has received U.S. Food and Drug Administration (FDA) clearance for its CRystalView T-Series desktop CR system at the 2007 RSNA meeting in Chicago.
November 26, 2007
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