Regulatory: Page 244

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
AMS gets Catella 510(k)
By AuntMinnie.com staff writers
American Medical Sales has received Food and Drug Administration 510(k) marketing clearance for its new PACS workstation software, Catella Version 4.0.
November 22, 2005
CardiArc seeks clearance for SPECT
By AuntMinnie.com staff writers
Cardiac imaging device developer CardiArc reported that it submitted a premarket notification 510(k) application with the Food and Drug Administration for a SPECT imaging device last month.
November 22, 2005
Toshiba notches 510(k) for Infinix VC-i
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received Food and Drug Administration 510(k) marketing clearance for its Infinix VC-i system with a large field-of-view 12 x 16-inch flat-panel detector.
November 21, 2005
Draxis iodine kit gets FDA approval
By AuntMinnie.com staff writers
Draxis Health reported that the FDA has approved its DraxImage division's new, larger format of its HiCon kit for the preparation of sodium iodide I-131 capsules and oral solution.
November 21, 2005
Radlink gets FDA approval for CR Pro
By AuntMinnie.com staff writers
Radiography equipment manufacturer Radlink of Torrance, CA, has received FDA clearance for the marketing and sale of its CR Pro computed radiography device.
November 17, 2005
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