Regulatory: Page 277

Making mammography more precise
By Brian Casey
Letter from the Editor: Several companies are working on new technologies that could become useful adjuncts to mammography, increasing detection rates and boosting precision by ruling out masses that don’t need to be biopsied.
February 25, 2003
Boston Scientific submits stent for PMA
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has submitted the first module of a premarket approval application for its Taxus paclitaxel-eluting coronary stent system to the Food and Drug Administration.
February 24, 2003
FDA clears Medis peripheral vascular software
By AuntMinnie.com staff writers
Medis Medical Imaging Systems has received Food and Drug Administration clearance for its QVA-CMS analytical software for use in quantitative analysis of vascular morphology in peripheral arteries.
February 24, 2003
Varian gets FDA OK for PaxScan
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for its PaxScan 4030 digital radiography system.
February 23, 2003
Terason adds applications to laptop ultrasound
By AuntMinnie.com staff writers
Burlington, MA-based Terason has received Food and Drug Administration clearance for two new applications for its Terason 2000 laptop ultrasound scanner.
February 20, 2003
ContextVision gets FDA OK for image enhancement system
By AuntMinnie.com staff writers
ContextVision of Randolph, VA, has received Food and Drug Administration 510(k) clearance for its SharpView stand-alone PC-based image enhancement workstation.
February 20, 2003
FDA clears another Barco display system
By AuntMinnie.com staff writers
Belgium-based BarcoView received 510(k) clearance in January from the Food and Drug Administration for its MeDis 5MP2 Aura dual-head CRT display for Windows NT PACS workstations.
February 20, 2003
Given Imaging gets reimbursement nod from Portugal
By AuntMinnie.com staff writers
Video-capsule manufacturer Given Imaging has received a favorable reimbursement decision from the Portuguese Ministry of Health for use of its M2A capsule endoscope.
February 19, 2003
HIPAA security: best practices drive implementation roadmap
By Jonathan S. Batchelor
Tom Walsh, a consultant on e-security practice with CTG Healthcare Solutions of Overland Park, KS, offers his insights on HIPAA best-practice security implementation, including risk assessment and analysis.
February 19, 2003
StorageTek, Stockell to offer HIPAA services
By AuntMinnie.com staff writers
StorageTek has joined forces with healthcare consulting firm Stockell to help customers achieve compliance with the Health Insurance Portability and Accountatiliby Act (HIPAA).
February 17, 2003
HHS issues HIPAA final security standards
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) has adopted the final security standards for protecting individually identifiable health information when it is maintained or transmitted electronically, as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
February 13, 2003
Fuji adds HIPAA-compliant tools to Synapse
By AuntMinnie.com staff writers
SAN DIEGO - Medical device developer Fujifilm Medical Systems USA of Stamford, CT, is set to release a set of advanced Synapse Web Administration Tools (SWAT) for its Synapse PACS, version 3.0.
February 12, 2003
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