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Regulatory: Page 221
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
AFP gets nod for conebeam CT scanner
By
AuntMinnie.com staff writers
Digital x-ray developer AFP Imaging has received approval to sell its conebeam CT scanner in Canada.
November 19, 2007
FDA clears Medtronic's biliary stent system
By
AuntMinnie.com staff writers
Interventional technology firm Medtronic has received clearance from the U.S. Food and Drug Administration (FDA) for its Complete SE (self-expanding) biliary stent system, the Minneapolis-based firm reported.
November 14, 2007
Israeli PACS firm gains FDA clearance
By
AuntMinnie.com staff writers
Israeli PACS developer CDP has received clearance from the U.S. Food and Drug Administration (FDA) for two multispecialty PACS offerings, the company reported.
November 14, 2007
Medstreaming nets FDA nod
By
AuntMinnie.com staff writers
Medstreaming of Seattle has received clearance from the U.S. Food and Drug Administration (FDA) to market its Medical Office suite of products.
November 13, 2007
Vote on MQSA oversight of breast biopsy split by specialty
By
Marty Graham
Earlier this week, the National Mammography Quality Assurance Advisory Committee advised the U.S. Food and Drug Administration (FDA) to expand the Mammography Quality Standards Act (MQSA) program to cover stereotactic breast biopsy. But the vote was not unanimous, with one group arguing that regulation was necessary, while others called it cumbersome.
November 7, 2007
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