Regulatory: Page 273

AuntMinnie's CT Radiology Insider
By Eric Barnes
Dr. Frank Earnest, director of CT practice for the Rochester, MN-based group, discusses the group's go-slow approach to CT screening at the 2003 International Symposium on Multidetector-Row CT.
September 28, 2003
Aurora gets 510(k) for RODEO breast imaging
By AuntMinnie.com staff writers
Breast MRI developer Aurora Imaging Technology of North Andover, MA, has received U.S. Food and Drug Administration 510(k) marketing clearance for its rotating delivery of excitation off-resonance (RODEO) breast imaging method.
September 25, 2003
Cardinal Health gets 510(k), NVLAP accreditation
By AuntMinnie.com staff writers
Healthcare firm Cardinal Health of Dublin, OH, said its Nuclear Associates subsidiary has received U. S. Food and Drug Administration 510(k) clearance for its CalRad Mark VI Dose Calibrator.
September 24, 2003
HIMSS offers advice on CMS contingency plan
By AuntMinnie.com staff writers
In light of the Centers for Medicare and Medicaid Services’ (CMS) contingency plan to accept non-compliant electronic HIPAA transactions after the October 16 deadline, the Healthcare Information Management Systems Society (HIMSS) has offered some recommendations for covered entities.
September 24, 2003
CMS to accept non-compliant transactions after October 16
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it would implement a contingency plan to accept non-compliant electronic transactions after the October 16, 2003 compliance deadline.
September 22, 2003
OmniCorder gets BioScanIR CE Mark
By AuntMinnie.com staff writers
Oncology and surgical product developer OmniCorder of East Seatauket, NY, has received CE Mark approval to market its BioScanIR thermal imaging system in the European Union.
September 22, 2003
OrthoView receives 510(k) clearance
By AuntMinnie.com staff writers
Medical applications developer Meridian Technique of Hampshire, U.K., has received U.S. Food and Drug Administration 510(k) pre-market clearance for its OrthoView digital templating software.
September 22, 2003
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
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