Regulatory: Page 214

Medrad gets 510(k) for FDG infusion system
By AuntMinnie.com staff writers
Contrast injector technology firm Medrad has received 510(k) clearance from the U.S. Food and Drug Administration for Intego, a PET radiopharmaceutical infusion system.
June 17, 2008
Elekta receives FDA nod
By AuntMinnie.com staff writers
Swedish radiation oncology firm Elekta has received U.S. Food and Drug Administration 510(k) clearance for its Volumetric Intensity Modulated Arc Therapy technology.
June 16, 2008
FDA to give GE's AdreView priority review
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has designated for priority review GE Healthcare's new drug application for AdreView, a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients.
June 12, 2008
GE revises Optison's prescribing information
By AuntMinnie.com staff writers
GE Healthcare of Chalfont St. Giles, U.K., has issued updates to the prescribing information for Optison (perflutren protein-type A microspheres injectable suspension, USP).
June 10, 2008
FDA to ease rules on digital mammography systems
By Brian Casey
June 9, 2008
FDA proposes easier regulatory path for FFDM systems
By Cynthia E. Keen
The U.S. Food and Drug Administration is proposing changes to the way it regulates full-field digital mammography (FFDM) systems. The move should make it easier and less costly for mammography vendors to bring FFDM systems to market when the new rules are scheduled to go into effect in 2009.
June 9, 2008
Siemens gets FDA nod for Definition AS
By AuntMinnie.com staff writers
Siemens Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Somatom Definition AS CT scanner.
June 8, 2008
FDA OKs Mindray US scanner
By AuntMinnie.com staff writers
Medical device manufacturer Mindray Medical International of Shenzhen, China, has received 510(k) clearance from the U.S. Food and Drug Administration for its DC-3 color ultrasound system.
June 5, 2008
FDA clears MR perfusion package
By AuntMinnie.com staff writers
Advanced visualization and analytical software solutions provider Imaging Biometrics of Milwaukee has received clearance from the U.S. Food and Drug Administration for its MR perfusion software package, IB Neuro.
June 5, 2008
NeuroLogica to bring CereTom to Korea
By AuntMinnie.com staff writers
Portable CT developer NeuroLogica said that its CereTom portable CT scanner has received clearance from the Korean Food and Drug Administration.
June 4, 2008
NordicNeuroLab nets 510(k) for new software
By AuntMinnie.com staff writers
Norwegian functional MRI developer NordicNeuroLab has received 510(k) clearance from the U.S. Food and Drug Administration to market its nordicAktiva software.
June 2, 2008
FDA clears Nucletron's treatment planning product
By AuntMinnie.com staff writers
Radiation oncology firm Nucletron of Veenendaal, Netherlands, has received clearance from the U.S. Food and Drug Administration (FDA) for its volume-based treatment planning software.
June 2, 2008
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