Regulatory: Page 243

Abbott gets approval for vessel closure device
By AuntMinnie.com staff writers
Interventional device firm Abbott Laboratories has received FDA approval for its StarClose vessel closure system.
December 22, 2005
Swissray gets FDA nod for flat-panel DR unit
By AuntMinnie.com staff writers
Digital radiography vendor Swissray International has received Food and Drug Administration 510(k) clearance for its ddRFormula flat-panel DR system.
December 20, 2005
Palatin suspends NeutroSpec distribution
By AuntMinnie.com staff writers
Contrast agent developer Palatin Technologies said it is voluntarily suspending sales, marketing, and distribution activities of its NeutroSpec radiopharmecutical imaging agent as a result of recently raised safety concerns.
December 18, 2005
Clario gets 510(k)
By AuntMinnie.com staff writers
Imaging processing developer Clario Medical Imaging has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its z3D Contrast Acuity software.
December 13, 2005
New 510(k) for Varian
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received FDA 510(k) clearance for a new proton therapy eye dose calculation module that has been incorporated into company's Eclipse radiation therapy treatment planning system.
December 6, 2005
Medipattern gets Canadian clearance
By AuntMinnie.com staff writers
Canadian computer-aided detection (CAD) software developer Medipattern of Toronto has received a medical device license from Health Canada for its B-CAD for breast ultrasound application.
December 5, 2005
FDA clears new Given software version
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging of Yoqneam, Israel, has received FDA clearance for the newest version of its operating software, Rapid 4.
December 5, 2005
Vascular Solutions receives Twin-Pass 510(k)
By AuntMinnie.com staff writers
Interventional technology developer Vascular Solutions of Minneapolis has received U.S. Food and Drug Administration 510(k) clearance for its Twin-Pass dual-access catheter, the firm reported.
December 1, 2005
DMS submits mammo system for FDA review
By AuntMinnie.com staff writers
Direct Medical Systems (DMS) of San Ramon, CA, has submitted an application to the FDA for clearance to market its M3000 mammography system.
November 28, 2005
Suros gets CE Mark for ATEC
By AuntMinnie.com staff writers
Interventional technology developer Suros Surgical Systems has received the European CE Mark for its ATEC Breast Biopsy and Excision System and ATEC TriMark biopsy site identification system.
November 27, 2005
Sorna gets FDA nod for Open LiteBox
By AuntMinnie.com staff writers
PACS technology developer Sorna has received FDA 510(k) clearance for its Open LiteBox software and LiteBox DICOM viewer.
November 23, 2005
Epix hit with Vasovist setback
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received a second approvable letter from the FDA regarding its Vasovist blood-pool contrast agent.
November 22, 2005
Previous Page
Page 243 of 302
Next Page