Regulatory: Page 227

Boston Scientific gets Japanese nod for Taxus
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific reported that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its Taxus Express² paclitaxel-eluting coronary stent system in Japan.
April 2, 2007
Stereotaxis gets FDA OK for ablation catheter
By AuntMinnie.com staff writers
Image-guided interventional surgery firm Stereotaxis of St. Louis said that its magnetically enabled 8-mm ablation catheter has received U.S. Food and Drug Administration (FDA) clearance and will soon be commercially available in the U.S.
April 2, 2007
CMS extends NPI implementation deadline
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has implemented a contingency plan for compliance with the May 23, 2007, deadline for the National Provider Identifier (NPI) provisions of HIPAA.
April 2, 2007
Maquet gets FDA OK
By AuntMinnie.com staff writers
Medical device developer Maquet Critical Care said that it has received U.S. Food and Drug Administration 510(k) clearance for MR conditional use of its Servo-i Ventilator system in an MRI suite.
March 22, 2007
FDA adds indication for Varian's brachytherapy applicator set
By AuntMinnie.com staff writers
Varian Medical Systems of Palo Alto, CA, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market an updated brachytherapy applicator set designed specifically for intraluminal treatment of cancer of the esophagus.
March 21, 2007
Health Canada issues gadolinium advisory
By AuntMinnie.com staff writers
The Canadian health regulatory agency Health Canada has issued a regulatory advisory to healthcare professionals in the country regarding the use of contrast agents containing gadolinium.
March 14, 2007
InSightec nets Canadian approval
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received approval from Health Canada for its ExAblate 2000 MR-guided focused ultrasound (MRgFUS) system.
March 11, 2007
European radiology mobilizes to stave off MRI safety rules
By Brian Casey
VIENNA - A number of European academic societies, including the European Society of Radiology (ESR), have formed a coalition to try to prevent the adoption of safety rules set to go into effect in 2008 that could severely limit the types of MRI studies that can be conducted in the European Union. Called the Alliance for MRI, the coalition was launched here today at the European Congress of Radiology (ECR).
March 8, 2007
Kodak nets Health Canada OK for CR mammo
By AuntMinnie.com staff writers
Eastman Kodak Health Group reported that it has received Health Canada approval for its DirectView CR mammography product.
March 5, 2007
InSightec nets FDA clearance for new software
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received U.S. Food and Drug Administration (FDA) clearance for a new software version for its ExAblate 2000 MR-guided focused ultrasound (MRgFUS) system.
March 4, 2007
Medtronic submits PMA for Talent Thoracic
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has submitted the final module of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Talent Thoracic stent-graft system.
March 4, 2007
NeuroLogica gets Canadian nod
By AuntMinnie.com staff writers
Mobile CT developer NeuroLogica has received the Canadian Medical Device License for its CereTom mobile CT scanner.
March 4, 2007
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