Regulatory: Page 234

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
EndoCare gets 510(k) for cryoablation device
By AuntMinnie.com staff writers
Cryoablation vendor Endocare has received 510(k) clearance from the U.S. Food and Drug Administration to market its new Cryocare CN2 system.
September 11, 2006
Advanced Magnetics adds execs
By AuntMinnie.com staff writers
MRI contrast developer Advanced Magnetics has appointed Dr. Louis Brenner as senior vice president and Mohammed Salem, Ph.D., as vice president of regulatory affairs.
September 10, 2006
Minrad nets CE Mark
By AuntMinnie.com staff writers
Interventional radiology image guidance developer Minrad International has received the European CE Mark for its Light Sabre product line.
September 10, 2006
Merge stock remains listed on Nasdaq
By AuntMinnie.com staff writers
Radiology IT and advanced visualization firm Merge Healthcare said it has received written notification from the Nasdaq stock exchange that it will continue listing the company's common stock on the Nasdaq Global Market.
September 10, 2006
FDA panel rejects Mirabel impedance breast device
By AuntMinnie.com staff writers
A U.S. Food and Drug Administration advisory committee last week voted unanimously that the premarket approval (PMA) application for a breast impedance imaging device be found "not approvable."
September 7, 2006
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