Regulatory: Page 274

Bard gets added clearance for vena cava filter
By AuntMinnie.com staff writers
Interventional technology developer C.R. Bard has received Food and Drug Administration clearance to market its Recovery vena cava filter as a removable device.
August 11, 2003
Aurora receives 510(k) for increased field strength
By AuntMinnie.com staff writers
Breast MRI developer Aurora Imaging Technology of North Andover, MA, has received Food and Drug Administration 510(k) marketing clearance for a new, 1.5-tesla version of its dedicated breast MRI scanner.
August 6, 2003
DraxImage begins Infecton Phase II trials
By AuntMinnie.com staff writers
DraxImage, a division of radiopharmaceutical firm Draxis Health of Mississauga, Ontario, has received Health Canada approval to begin phase II clinical studies of its radiopharmaceutical Infecton.
July 30, 2003
Advanced Magnetics gets U.S. patent
By AuntMinnie.com staff writers
Contrast agent developer Advanced Magnetics has received a U.S. patent related to the company’s next-generation iron oxide technology.
July 30, 2003
EP MedSystems seeks 510(k) for integrated system
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems has requested a 510(k) regulatory clearance filing with the Food and Drug Administration for the integration of its WorkMate intracardiac ultrasound catheter system with Boston Scientific’s Realtime Position Management technology.
July 23, 2003
Celsion receives CPT code
By AuntMinnie.com staff writers
Celsion has received a current procedural terminology (CPT) code from the American Medical Association for its investigational thermal therapy system for ablation/reduction of malignant breast tumors, the company reported.
July 23, 2003
FDA ruling opens door to new PACS storage options
The task of choosing data-storage solutions continues to be muddied by misunderstood or misrepresented regulatory concerns, as well as an ongoing turf battle among PACS and storage-technology vendors. A recent Food and Drug Administration clarification may change all that. Stuart C. Gardner and Kris K. Hughes of SG&A Consulting explain how.
July 23, 2003
Varian releases planning software, receives 510(k)
By AuntMinnie.com staff writers
X-ray and radiation therapy developer Varian Medical Systems of Palo Alto, CA, has released the latest iteration of its Eclipse 3-D radiotherapy treatment-planning software for image-guided radiotherapy.
July 17, 2003
Given Imaging gets Israeli reimbursement
By AuntMinnie.com staff writers
Video-capsule manufacturer Given Imaging of Yoqneam, Israel, said that Menora Insurance, one of Israel’s largest insurance companies, has issued reimbursement coverage for use of its M2A capsule endoscope for direct imaging of the entire small intestine.
July 2, 2003
Guidant and OIG reach agreement
By AuntMinnie.com staff writers
Interventional firm Guidant has entered into a corporate integrity agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services.
June 30, 2003
R2's ImageChecker CT set for FDA review
By AuntMinnie.com staff writers
R2 Technology's pre-market approval (PMA) application for its ImageChecker CT computer-aided detection system has been accepted for review by the Food and Drug Administration.
June 24, 2003
Boston Scientific submits final module for Taxus trials
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has submitted the fifth and final module of its premarket application (PMA) for its Taxus Express 2 paclitaxel-eluting coronary stent system.
June 18, 2003
Previous Page
Page 274 of 302
Next Page