Regulatory: Page 235

Cordis gets CE Mark for Cypher Select
By AuntMinnie.com staff writers
Johnson & Johnson subsidiary Cordis Endovascular has received the European CE Mark for its Cypher Select sirolimus-eluting stent.
September 5, 2006
FDA rejects Epix appeal
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals said that the U.S. Food and Drug Administration (FDA) has denied its formal appeal to approve its Vasovist blood-pool imaging agent.
August 27, 2006
GE, Volcano get 510(k) for integrated DR/US product
By AuntMinnie.com staff writers
Multimodality vendor GE Healthcare and intravascular ultrasound (IVUS) developer Volcano of Rancho Cordova, CA, said that they have received U.S. Food and Drug Administration 510(k) clearance to integrate products.
August 23, 2006
Elekta gets FDA nod
By AuntMinnie.com staff writers
Swedish radiation therapy firm Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Gamma Knife Perfexion stereotactic radiosurgery system.
August 22, 2006
NEMA publishes new FFDM QC standards
By AuntMinnie.com staff writers
The National Electrical Manufacturers Association (NEMA) has published new test standards for the quality assurance plans of displays, workstations, and hard-copy output devices labeled for final interpretation in an full-field digital mammography (FFDM) system.
August 14, 2006
Epix nears Australia approval for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals said that the Australian Drug Evaluation Committee (ADEC) has recommended the firm's Vasovist blood pool imaging agent for approval in Australia.
August 13, 2006
Hologic completes FTC settlement
By AuntMinnie.com staff writers
Women's imaging vendor Hologic of Bedford, MA, reported that the U.S. Federal Trade Commission (FTC) has given its final approval to a consent agreement regarding the acquisition of the Mammotest prone bed breast biopsy system from Denver-based Fischer Imaging last year.
August 9, 2006
Calypso receives 510(k)
By AuntMinnie.com staff writers
Electromagnetic localization developer Calypso Medical Technologies has been granted 510(k) clearance by the U.S. Food and Drug Administration for its Calypso 4D localization system.
August 7, 2006
Cook to bring Zenith graft to Japan
By AuntMinnie.com staff writers
Interventional technology developer Cook has received approval to market its Zenith endovascular graft system in Japan.
August 6, 2006
Totoku gets FDA OK for mammo display
By AuntMinnie.com staff writers
Japanese monitor manufacturer Totoku Electric has received U.S. Food and Drug Administration 510(k) clearance for its ME551i2 monochrome digital mammography display.
August 1, 2006
HHS releases final 'safe harbors' rules for health IT
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) yesterday released final regulations expected to make it easier for physicians to adopt electronic health records (EHR) technology.
August 1, 2006
Fuji adds to Synapse, DryPix
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received Food and Drug Administration 510(k) clearance for Obliquus, an integrated 3D software package for its Synapse PACS network.
July 31, 2006
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