Regulatory: Page 208

Merit adds to product line
By AuntMinnie.com staff writers
Disposable products developer Merit Medical Systems has added two new devices to its product line and received clearance from the U.S. Food and Drug Administration for its contrast management system.
December 29, 2008
Epix gets FDA OK for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received approval from the U.S. Food and Drug Administration to market its blood pool MR angiography contrast agent.
December 22, 2008
IMRIS nets FDA OK for 3T MRI
By AuntMinnie.com staff writers
Canadian intraoperative MRI technology developer IMRIS has received clearance from the U.S. Food and Drug Administration for its 3-tesla IMRISneuro.
December 18, 2008
Naviscan ends trial enrollment, gets FDA OK
By AuntMinnie.com staff writers
PET developer Naviscan recently completed enrollment for a 400-patient randomized prospective trial, which the company is sponsoring with the U.S. National Institutes of Health.
December 18, 2008
IBA gets FDA nod for pencil-beam scanning
By AuntMinnie.com staff writers
Radiopharmaceutical firm Ion Beam Applications (IBA) has received clearance from the U.S. Food and Drug Administration for its pencil-beam scanning treatment option for proton therapy.
December 18, 2008
Vida software nets FDA OK
By AuntMinnie.com staff writers
Vida Diagnostics has received approval from the U.S. Food and Drug Administration for its Pulmonary Workstation 2.0 lung image analysis software.
December 16, 2008
Visage gets FDA nod
By AuntMinnie.com staff writers
Advanced visualization firm Visage Imaging has received U.S. Food and Drug Administration 510(k) approval for its Visage CS 3.1 thin-client software release.
December 15, 2008
GE, Deep Breeze debut lung imaging system
By AuntMinnie.com staff writers
GE Healthcare and partner Deep Breeze have received U.S. Food and Drug Administration 510(k) marketing clearance for their VRIxv lung imaging system.
December 14, 2008
Siemens gets FDA OK for IQ-SPECT
By AuntMinnie.com staff writers
Siemens Healthcare has received clearance from the U.S. Food and Drug Administration for IQ-SPECT.
December 14, 2008
FDA panel rejects Acusphere contrast agent
By AuntMinnie.com staff writers
A U.S. Food and Drug Administration panel rejected the regulatory application for the Imagify ultrasound contrast agent from Acusphere of Watertown, MA.
December 10, 2008
IBA responds to FDA warning letter
By AuntMinnie.com staff writers
Radiopharmaceutical firm Ion Beam Applications (IBA) has responded to a warning letter from the U.S. Food and Drug Administration related to manufacturing practices for PET radiotracers at a facility in Virginia.
December 10, 2008
Viatronix releases V3D-Cardiac
By AuntMinnie.com staff writers
Advanced visualization firm Viatronix has received U.S. Food and Drug Administration 510(k) approval for its V3D-Cardiac module.
December 8, 2008
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