Regulatory: Page 259

Analogic gets 510(k) for new flat-panel detector
By AuntMinnie.com staff writers
Analogic has received 510(k) clearance from the Food and Drug Administration for the GR17 flat-panel digital detector developed by Analogic subsidiary Anrad.
November 1, 2004
SonoVue reinstated for echo use
By AuntMinnie.com staff writers
The SonoVue ultrasound contrast agent from Bracco of Milan, Italy, has been reinstated for use in echocardiography applications in Europe by the Commission of the European Communities, the executive body of the European Union.
October 31, 2004
Confirma brings CADstream to Europe
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Confirma has received the European CE Mark for its CADstream MRI CAD system.
October 28, 2004
Siemens scores cardiac MR patent
By AuntMinnie.com staff writers
Siemens Medical Solutions has received a U.S. parent for cardiac MR self-gating, a technology designed to eliminate the need to obtain an electrocardiogram (ECG) signal during imaging.
October 27, 2004
Emageon gets OK for digital mammo viewing
By AuntMinnie.com staff writers
Image management firm Emageon has received Food and Drug Administration (FDA) clearance to use its UltraVisual advanced visualization software for soft-copy viewing of digital mammography images in conjunction with FDA-approved display hardware.
October 27, 2004
Unfors gets nod for dosimeter
By AuntMinnie.com staff writers
Radiation calibration and measuring instrument firm Unfors Instruments has received Food and Drug Administration 510(k) clearance for its Patient Skin Dosimeter (PSD).
October 27, 2004
Medicsight gets FDA nod for Colon CAR
By AuntMinnie.com staff writers
Image analysis software developer Medicsight has received U.S. Food and Drug Administration marketing clearance for its Colon Computed Assisted Reader (CAR) 1.2 software.
October 26, 2004
Given gets U.S. OK for esophagus imaging device
By AuntMinnie.com staff writers
Video-capsule manufacturer Given Imaging has received marketing clearance from the U.S. Food and Drug Administration for its Given Diagnostic System, including the PillCam ESO video capsule for imaging the esophagus, according to the Yoqneam, Israel-based firm.
October 25, 2004
GE partners with InSightec
By AuntMinnie.com staff writers
GE Healthcare and noninvasive therapy technology developer InSightec have collaborated to introduce an MR image-guided focused ultrasound system.
October 24, 2004
ev3 stent gets 510(k)
By AuntMinnie.com staff writers
Interventional device firm ev3 of Plymouth, MN, has received Food and Drug Administration 510(k) marketing clearance for its Protégé GPS nitinol self-expanding long stent.
October 20, 2004
Advanced Magnetics, Cytogen get FDA nod
By AuntMinnie.com staff writers
MR contrast developer Advanced Magnetics and biopharmaceutical firm Cytogen said they have submitted a complete response to the approvable letter received from the Food and Drug Administration for Combidex, Advanced Magnetics' investigational molecular imaging agent.
October 19, 2004
ABR issues nuclear radiology update
By AuntMinnie.com staff writers
The American Board of Radiology (ABR) reported that the U.S. Nuclear Regulatory Commission (NRC) has delayed a final decision on proposed new regulations that govern the training and experience required to use radioactive materials commonly employed in clinical nuclear radiology until October 24, 2005.
October 13, 2004
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