Regulatory: Page 241

Analogic gets FDA nod for wide-beam transducer
By AuntMinnie.com staff writers
Medical imaging firm Analogic has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its wide-beam fetal ultrasound transducer.
March 29, 2006
Quest touts mammo clearance for Totoku LCD
By AuntMinnie.com staff writers
Monitor distributor Quest International said that Totoku's ME511L has been given U.S. Food and Drug Administration 510(k) clearance for use in all digital mammography applications.
March 27, 2006
Medtronic gets FDA nod for AAA stent system
By AuntMinnie.com staff writers
Medical device developer Medtronic has received U.S. Food and Drug Administration clearance for its AneuRx AAAdvantage abdominal aortic aneurysm (AAA) stent graft with Xcelerant delivery system.
March 27, 2006
ArthroCare gets FDA nod
By AuntMinnie.com staff writers
Medical device firm ArthroCare has received U.S. Food and Drug Administration (FDA) clearance for its Parallax Integrated Delivery System (IDS), an enclosed device used for mixing and delivery of cement during vertebroplasty and kyphoplasty procedures.
March 22, 2006
Hitachi gets FDA proton beam device approval
By AuntMinnie.com staff writers
Multimodality developer Hitachi Medical Systems America said it has received Food and Drug Administration clearance for commercialization of Hitachi's ProBeat Proton Beam Therapy System in the U.S.
March 20, 2006
Salix gets FDA OsmoPrep OK
By AuntMinnie.com staff writers
Salix Pharmaceuticals of Raleigh, NC, said that it has received U.S. Food and Drug Administration marketing approval for its OsmoPrep Tablets.
March 19, 2006
St. Jude gets FDA nod for Angio-Seal VIP
By AuntMinnie.com staff writers
Medical device manufacturer St. Jude Medical reported that has received Food and Drug Administration clearance for its Angio-Seal VIP vascular closure device.
March 16, 2006
Del Medical gets Chinese sign-off
By AuntMinnie.com staff writers
Del Medical Systems Group's manufacturing facilities in Franklin Park, IL, have completed the final testing required by Beijing-based China Quality Certification Center regulators for digital production.
March 16, 2006
Biosense Webster, Cordis get Noga XP FDA clearance
By AuntMinnie.com staff writers
Cardiac technology developer Biosense Webster and Johnson & Johnson subsidiary Biologics Delivery Systems Group, Cordis has received U.S. Food and Drug Administration clearance to market a cardiac 3D imaging device, the Noga XP cardiac navigation system.
March 15, 2006
GE receives Innova 510(k) clearance
By AuntMinnie.com staff writers
GE Healthcare said that the U.S. Food and Drug Administration has provided 510(k) clearance for its Innova 3131(IQ) and 2121(IQ) digital flat-panel biplane imaging systems.
March 13, 2006
ev3 stent gets FDA, CE stent nods for Protege
By AuntMinnie.com staff writers
Interventional device firm ev3 of Plymouth, MN, has received Food and Drug Administration 510(k) clearance to market its Protege EverFlex self-expanding stent system for the palliative treatment of malignant neoplasms in the biliary tree.
March 9, 2006
Guidant launches new stent
By AuntMinnie.com staff writers
Interventional device developer Guidant has launched the RX HercuLink Elite biliary stent system in the U.S., following Food and Drug Administration 510(k) clearance.
March 9, 2006
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