Regulatory: Page 225

Sectra applies for U.S. OK for MicroDose
By AuntMinnie.com staff writers
Swedish PACS and digital mammography provider Sectra has submitted the first part of an application to the U.S. Food and Drug Administration (FDA) for marketing clearance for its Sectra MicroDose Mammography system.
June 27, 2007
Imaging3 files 510(k) for Dominion 3D
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 has filed a 510(k) submission for its Dominion 3D real-time imaging device with the U.S. Food and Drug Administration (FDA).
June 18, 2007
Epix receives FDA response
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received a response from its appeal to the U.S. Food and Drug Administration (FDA) asking for immediate approval of its Vasovist agent.
June 18, 2007
Given Imaging gets FDA nod for esophagus imaging pill
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging of Yoqneam, Israel, has received U.S. clearance to market its upgraded PillCam ESO 2 video capsule for imaging of the esophagus.
June 17, 2007
Median gets 510(k) for lung and liver apps
By AuntMinnie.com staff writers
French computer-aided detection (CAD) developer Median Technologies has received 510(k) clearance from the U.S. Food and Drug Administration for its LMS-Lung/Track and LMS-Liver applications.
June 17, 2007
Viatronix, Medicsight net CE Mark
By AuntMinnie.com staff writers
Advanced visualization firm Viatronix and computer-aided detection (CAD) partner Medicsight of London have jointly released their integrated virtual colonoscopy CAD offering in Europe.
June 12, 2007
Konica Minolta shows Nano CR line at SIIM
By AuntMinnie.com staff writers
Konica Minolta Medical Imaging USA of Wayne, NJ, gave attendees at last week's Society for Imaging Informatics in Medicine (SIIM) conference in Providence, RI, a look at the company's new compact computed radiography (CR) product.
June 10, 2007
Barco gets 510(k) for advanced visualization suite, launches new PACS display
By AuntMinnie.com staff writers
Image display and advanced visualization software developer Barco said it has received U.S. Food and Drug Administration (FDA) approval for the latest version of its Voxar 3D advanced visualization software suite. The Kortrijk, Belgium-based firm also launched a new PACS color display system.
June 6, 2007
InSightec nabs CE Mark
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec announced that its ExAblate 2000 system has received the European CE Mark certification for pain palliation of bone metastases.
June 6, 2007
Swissray gets FDA nod
By AuntMinnie.com staff writers
Digital radiography (DR) developer Swissray International has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ddRCompact series of DR systems.
June 4, 2007
Imaging3 readies FDA filing
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 said it expects to soon file a 510(k) submission with the U.S. Food and Drug Administration (FDA) for its Dominion 3D imaging device.
June 4, 2007
FDA OKs Segami's DGScope
By AuntMinnie.com staff writers
Nuclear medicine software developer Segami of Columbia, MD, has received U.S. Food and Drug Administration (FDA) clearance for its DGScope digital image viewing technology.
May 31, 2007
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