Regulatory: Page 234

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
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
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