Regulatory: Page 237

Cordis Cypher Select Plus nets CE Mark
By AuntMinnie.com staff writers
Johnson & Johnson subsidiary Biologics Delivery Systems Group, Cordis reported that its third-generation drug-eluting stent, the Cypher Select Plus, has received CE Mark approval.
June 21, 2006
Medtronic to bring Endeavor to China
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received regulatory approval from the government of the People's Republic of China for its Endeavor drug-eluting coronary stent system.
June 20, 2006
InSightec to bring Exablate to Australia, Taiwan
By AuntMinnie.com staff writers
Israeli focused-ultrasound developer InSightec has received regulatory approval from the Australian and Taiwanese governments for the commercial distribution of its ExAblate 2000 MR-guided focused ultrasound (MRgFUS) system.
June 20, 2006
Imagin nets regulatory approval
By AuntMinnie.com staff writers
PET and PET/CT imaging center developer Imagin Molecular said its wholly owned subsidiary Imagin Nuclear Partners (INP) has received regulatory approval to bill Medicare and Medicaid for PET imaging services.
June 18, 2006
St. Jude Medical gets CE Mark
By AuntMinnie.com staff writers
Medical device manufacturer St. Jude Medical of St. Paul, MN, reported that it has received European CE Mark approval for its QuickOpt timing cycle optimization application.
June 15, 2006
FDA issues gadolinium health advisory
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has issued a health advisory regarding MRI contrast agents containing gadolinium after two dozen cases of a rare disease that developed in European patients following administration of a gadolinium-based agent.
June 14, 2006
FDA awards 510(k) to Barco's CardiaMetrix
By AuntMinnie.com staff writers
Image display and advanced visualization software developer Barco of Kortrijk, Belgium, has received 510(k) clearance from the U.S. Food and Drug Administration for its CardiaMetrix software.
June 13, 2006
Elekta nets Japanese approval
By AuntMinnie.com staff writers
Swedish radiation therapy firm Elekta has received approval from the Japanese Ministry for Health, Labor, and Welfare for its Synergy image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT) systems.
June 13, 2006
Given gets FDA OK for real-time device
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging of Yoqneam, Israel, has received U.S. Food and Drug Administration marketing clearance for its Rapid Access RT product.
June 12, 2006
Medtronic nets French reimbursement approval
By AuntMinnie.com staff writers
Interventional technology firm Medtronic said it has received reimbursement approval in France for its Endeavor drug-eluting coronary stent system.
June 11, 2006
FDA clears GE nuclear cardiology software
By AuntMinnie.com staff writers
GE Healthcare of Chalfont St. Giles, U.K., has received U.S. Food and Drug Administration clearance for a new software package for the fusion of PET/CT and SPECT/CT cardiac studies.
June 11, 2006
Medrad gets 3-tesla clearance
By AuntMinnie.com staff writers
Contrast injector technology firm Medrad said that it has received U.S. Food and Drug Administration clearance for use of its Continuum MR infusion system in MR environments up to and including 3 tesla.
June 7, 2006
Previous Page
Page 237 of 302
Next Page