Regulatory: Page 226

Sapheneia gets clearance for Clarity
By AuntMinnie.com staff writers
Advanced visualization firm Sapheneia of Jackson, MS, has received clearance from the U.S. Food and Drug Administration for Sapheneia Clarity, a server technology for image enhancement and processing of radiology images.
May 13, 2007
IRS gives nod to nonprofit EHR subsidies
By AuntMinnie.com staff writers
In a move that could boost adoption of electronic health records (EHRs), the Internal Revenue Service (IRS) has issued a memorandum stating that nonprofit hospitals can offer subsidies to affiliated physicians to buy EHR software without jeopardizing their nonprofit status.
May 13, 2007
Boston Scientific brings Taxus Express² to Japan
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has launched its Taxus Express² paclitaxel-eluting coronary stent system in Japan.
May 7, 2007
ARRS speaker: DRA may not be end of imaging payment cuts
By Wayne Forrest
ORLANDO - The fight to repeal the Deficit Reduction Act (DRA) of 2005 is not over -- and neither is the potential for more payment cuts. At least, that's according to Dr. Arl Van Moore Jr., chairman of the Board of Chancellors at the American College of Radiology, who opened this week's American Roentgen Ray Society (ARRS) meeting on a cautionary note.
May 6, 2007
Hansen Medical nets FDA OK for robotic technology
By AuntMinnie.com staff writers
Robotic technology developer Hansen Medical of Mountain View, CA, has received clearance from the U.S. Food and Drug Administration (FDA) to market its Sensei robotic catheter system and Artisan control catheter.
May 3, 2007
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
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