Regulatory: Page 225

Siemens gets IND for study of FLT tracer
By AuntMinnie.com staff writers
Siemens Medical Solutions has received an investigational new drug exemption from the U.S. Food and Drug Administration to conduct a phase I clinical trial of a new radiopharmaceutical for cancer detection.
July 29, 2007
Alliance for MRI gains delay, but new European rules still loom
By Brenda Tilke
A coalition of European MRI advocates won a partial victory in June in its fight against new safety regulations that some believe will effectively shut down the use of MRI across the European Union. But the Alliance for MRI, led by the European Society of Radiology (ESR) of Vienna, faces additional struggle in winning a permanent injunction against implementation of the rules.
July 25, 2007
DraxImage files for European clearance
By AuntMinnie.com staff writers
Canadian radiopharmaceutical firm DraxImage has filed an application for its sestamibi kit with European regulatory authorities.
July 24, 2007
CMS unveils deals, FDA submission
By AuntMinnie.com staff writers
Radiation treatment planning firm CMS of St. Louis will provide treatment planning support for a new single-room proton beam radiotherapy system being developed by Still River Systems of Littleton, MA.
July 22, 2007
Advocacy group calls for more FDA funding
By AuntMinnie.com staff writers
The FDA Alliance, a coalition of more than 100 organizations and individuals, said the U.S. House of Representatives' appropriations subcommittee on agriculture's allocation of $1.7 billion for the Food and Drug Administration (FDA) fiscal-year 2008 budget is not enough.
July 12, 2007
U.S. House reauthorizes MDUFMA
By AuntMinnie.com staff writers
The U.S. House of Representatives has voted to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA II).
July 11, 2007
Biospace files 510(k) application
By AuntMinnie.com staff writers
French digital radiography developer Biospace Med has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its EOS orthopedic 2D/3D x-ray imager.
July 8, 2007
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
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