Regulatory: Page 227

HHS establishes office to manage BARDA
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) has created an office to manage the Biomedical Advanced Research and Development Authority (BARDA).
April 26, 2007
iCAD's SecondLook receives Japanese approval
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer iCAD of Nashua, NH, has received approval from Japan's Ministry of Health, Labor and Welfare for its SecondLook digital CAD system to support full-field digital mammography products from GE Healthcare.
April 23, 2007
GE gets nod for VCAR for PET
By AuntMinnie.com staff writers
GE Healthcare has been issued a 510(k) clearance notification by the U.S. Food and Drug Administration for its PET Volume Computed Assisted Reading (VCAR) software.
April 19, 2007
FDA recommends medical device user fee reauthorization
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA).
April 16, 2007
E-Z-EM gets FDA nod for EmpowerMR
By AuntMinnie.com staff writers
Contrast and virtual colonoscopy accessory developer E-Z-EM has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its EmpowerMR contrast injector system.
April 16, 2007
Dynamic scores Health Canada OK
By AuntMinnie.com staff writers
PACS developer Dynamic Imaging said that it has received a medical device license for its IntegradWeb PACS from Health Canada.
April 9, 2007
Initia-RT nets CE Mark
By AuntMinnie.com staff writers
Radiation therapy firm Initia-RT has received the European CE Mark for its CrossPlan treatment planning software.
April 8, 2007
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
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