Regulatory: Page 233

Boston nets CE Mark
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received the European CE Mark for its Promus everolimus-eluting coronary stent system.
October 15, 2006
Cook gets CE Mark for endovascular graft
By AuntMinnie.com staff writers
Interventional firm Cook said that it has received European CE Mark approval for its Zenith Branch endovascular graft.
October 9, 2006
NeuroLogica nets CE Mark
By AuntMinnie.com staff writers
Mobile CT developer NeuroLogica has received the European CE Mark for its CereTom portable CT scanner.
October 8, 2006
FDA OKs Rendoscopy's 3D software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has given 510(k) clearance to Rendoscopy's Gentle Colon virtual colonoscopy 3D visualization software.
October 4, 2006
eRad scores CE Mark
By AuntMinnie.com staff writers
PACS firm eRad has received the CE Mark for its PACS offering.
September 27, 2006
MDS Nordion gets FDA OK for TheraSphere clinical trials
By AuntMinnie.com staff writers
Canadian radioisotope developer MDS Nordion reported that it has received U.S. Food and Drug Administration (FDA) approval to begin clinical trials of its TheraSphere treatment for liver cancer.
September 25, 2006
CMS starts nine-day hold on Medicare claims payment
By AuntMinnie.com staff writers
Starting today, the U.S. Centers for Medicare and Medicaid Services (CMS) will put a hold on payment for all Medicare claims through September 30.
September 21, 2006
Epix nets Australian approval
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received approval from the Australian Therapeutic Goods Administration (TGA) to market its Vasovist blood-pool imaging agent.
September 19, 2006
Medtronic gets Japanese OK for Micro-Driver stent
By AuntMinnie.com staff writers
Interventional technology firm Medtronic said that it has received Japanese regulatory approval and will begin sales in the country of its Micro-Driver coronary stent system.
September 19, 2006
Bill passed to require EHR capabilities for federal employees
By AuntMinnie.com staff writers
The U.S. House Government Reform Subcommittee on the Federal Workforce and Agency Organization passed a bill yesterday to amend chapter 89 of title 5 of the United States Code, to provide for the implementation of a system of electronic health records (EHRs) under the Federal Employees Health Benefits Program (FEHBA).
September 13, 2006
Abbott nets CE Mark for Emboshield Pro
By AuntMinnie.com staff writers
Interventional firm Abbott Vascular has received the European CE Mark for its Emboshield Pro embolic protection device.
September 12, 2006
Hologic receives DEXA 510(k) clearance
By AuntMinnie.com staff writers
Women's imaging vendor Hologic of Bedford, MA, reported that the U.S. Food and Drug Administration has cleared the company's Hip Structure Analysis (HSA) software for use in its dual-energy x-ray (DEXA) bone densitometers.
September 12, 2006
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