Regulatory: Page 254

RADIN gets 510(k) for PACS
By AuntMinnie.com staff writers
German PACS software developer RADIN has received 510(k) clearance from the U.S. Food and Drug Administration for its RADIN PACS software.
March 9, 2005
FDA denies Biofield regulatory request
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has turned down an appeal from breast technology developer Biofield that would have made it easier for the Atlanta-based company to get its flagship product through the regulatory approval process.
March 8, 2005
FDA clears Siemens' smaller US catheter
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its Acuson AcuNav 8F ultrasound catheter, which is 33% smaller than the AcuNav 10F catheter.
March 8, 2005
Barco receives FDA nods
By AuntMinnie.com staff writers
Display provider Barco has received U.S. Food and Drug Administration 510(k) clearance for its Colonscreen CT colonography software.
March 3, 2005
CoActiv gets mammo approval for Exam-PACS
By AuntMinnie.com staff writers
PACS firm CoActiv Medical Business Solutions has received U.S. Food and Drug Administration clearance to deploy its Exam-PACS network for primary reading and storage of digital mammography exams.
March 2, 2005
Siemens gets MammoReport(Plus) clearance
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received U.S. Food and Drug Administration 510(k) marketing clearance for its mammography soft-copy reporting workstation, MammoReport(Plus).
February 23, 2005
Elekta Beam Modulator gets 510(k) nod
By AuntMinnie.com staff writers
Radiation therapy provider Elekta has received U.S. Food and Drug Administration 510(k) marketing clearance for its Elekta Beam Modulator, a multileaf collimator designed for use with its medical linear accelerators.
February 23, 2005
New patents for Biophan
By AuntMinnie.com staff writers
MRI device developer Biophan Technologies said it has received two new patents from the U.S. Patent and Trademark Office.
February 23, 2005
GE expands orthopedic offerings
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for OEC Fluorostar, a digital C-arm designed to provide fluoroscopic images during diagnostic, surgical, and interventional procedures.
February 23, 2005
R2 gets FDA nod for CAD with Mammomat
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer R2 Technology has received U.S. Food and Drug Administration clearance to expand the use of its ImageChecker D product for CAD processing of images acquired with Siemens Medical Solutions' Mammomat NovationDR full-field digital mammography system (FFDM) and viewed on Siemens' MammoReportPlus soft-copy reporting workstation.
February 22, 2005
CMS activates CPT codes for PET
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it has adopted current procedural terminology (CPT) codes for PET procedure reimbursement, essentially discontinuing previously used G series Healthcare Common Procedure Coding System (HCPCS) codes.
February 21, 2005
Brailer outlines national health IT goals, challenges at HIMSS
By Jonathan S. Batchelor
DALLAS - Healthcare information technology isn't about software and computers. IT exists to help physicians make better treatment decisions, nurses and pharmacists deliver safer care, and consumers make better choices among treatment options, according to Dr. David Brailer, U.S. Health and Human Services National Coordinator for Health Information Technology.
February 17, 2005
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