Regulatory: Page 240

Kodak gets FDA OK on cardiac PACS apps
By AuntMinnie.com staff writers
Eastman Kodak Health Group has received U.S. Food and Drug Administration clearance for specialized cardiac functions in its CareStream PACS application.
April 10, 2006
Maxant gets 510(k) for MediPort
By AuntMinnie.com staff writers
X-ray illuminator firm Maxant Technologies of Niles, IL, has received U.S. Food and Drug Administration 510(k) clearance for its MediPort line of digital workstations.
April 6, 2006
Boston Scientific resolves Guidant antitrust issues
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said it had signed an agreement containing consent orders from the U.S. Federal Trade Commission that would resolve the agency's antitrust concerns over the proposed acquisition of Guidant.
April 5, 2006
Siemens gets 510(k) for MVision
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its MVision Megavoltage Cone Beam imaging package for radiation therapy applications.
April 3, 2006
Siemens gets clearance for Axiom upgrades
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions of Malvern, PA, has received U.S. Food and Drug Administration 510(k) clearance for a pair of new technologies for its Axiom vascular imaging systems.
March 29, 2006
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
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