Regulatory: Page 273

R2 gets FDA okay for ImageChecker DM
By AuntMinnie.com staff writers
Computer-aided detection developer R2 Technology has received Food and Drug Administration clearance for its ImageChecker DM CAD system with OmniCAD technology.
September 21, 2003
U.K. study to examine CAD’s effectiveness
By AuntMinnie.com staff writers
A group of hospitals in the U.K. has launched a study of the effectiveness of computer-aided detection (CAD) in a mammography screening environment.
September 16, 2003
FDA OKs ACR as Selenia accrediting body
By AuntMinnie.com staff writers
The Food and Drug Administration has approved the American College of Radiology (ACR) as the accrediting body for the Lorad Selenia full-field digital mammography (FFDM) system.
September 16, 2003
HIPAA transaction storm looms on the horizon
By Brian Casey
As the eastern U.S. braces for the imminent arrival of Hurricane Isabel, another potential disaster is looming on the horizon: the implementation of transaction standards for the Health Insurance Portability and Accountability Act.
September 16, 2003
FDA sets date to review Boston Scientific stent
By AuntMinnie.com staff writers
The Food and Drug Administration will hold a special panel hearing on November 20 to review Boston Scientific’s premarket approval (PMA) application for the Taxus Express2 paclitaxel-eluting coronary stent.
September 15, 2003
Boston Scientific’s Taxus stent receives Canadian approval
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has received approval from Health Canada’s Therapeutic Products Directorate for the sale of its Taxus Express2 paclitaxel-eluting coronary stent system in Canada.
September 11, 2003
B. Braun injector system gets 510(k)
By AuntMinnie.com staff writers
B. Braun Medical has received Food and Drug Administration clearance for its Ultrasite needle-free IV system for interventional radiology applications.
September 10, 2003
Boston Scientific, CryoVascular form alliance
By AuntMinnie.com staff writers
Boston Scientific and CryoVascular Systems have signed a series of agreements.
September 10, 2003
Siemens gets OK for Oncor Avant-Garde
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration 510(k) clearance for its Oncor Avant-Garde linear accelerator.
September 9, 2003
Cordis stent gets FDA OK
By AuntMinnie.com staff writers
Interventional technology developer Cordis Endovascular has received Food and Drug Administration clearance for the use of its S.M.A.R.T. Nitinol stent and S.M.A.R.T. Control Nitinol stent for primary stenting of the iliac arteries.
September 4, 2003
Henry Schein divests PMA Bode
By AuntMinnie.com staff writers
Healthcare products and services provider Henry Schein of Melville, NY, has entered into an agreement to divest its PMA Bode business.
September 1, 2003
CADx gets FDA nod for Second Look systems
By AuntMinnie.com staff writers
Computer-aided detection developer CADx Systems has received Food and Drug Administration clearance for its Second Look Digital and Second Look AD systems.
August 12, 2003
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