Regulatory: Page 212

Meta Imaging nets 510(k) for breast system
By AuntMinnie.com staff writers
Meta Imaging Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its Chrysalis breast displacement system.
August 19, 2008
GE IT unit gets warning letter
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has issued a warning letter to GE Healthcare's Integrated IT Solutions business due to recordkeeping procedures at its Barrington, IL, facility.
August 18, 2008
Dräger gets clearance for MRI anesthesia unit
By AuntMinnie.com staff writers
Medical products firm Dräger Medical has received U.S. Food and Drug Administration clearance for its Fabius MRI anesthesia machine.
August 18, 2008
Ashva nets FDA nod
By AuntMinnie.com staff writers
Indian PACS vendor Ashva Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Edge PACS offering.
August 18, 2008
FiatLux nets FDA clearance
By AuntMinnie.com staff writers
Advanced visualization software developer FiatLux Imaging has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Visualize software.
August 17, 2008
Paramed wins FDA approval for cryogen-free MRI
By AuntMinnie.com staff writers
Paramed Medical Systems has received FDA approval for MRopen, a new cryogen-free MRI scanner.
August 11, 2008
FDA clears Medrad's wireless MR infusion system
By AuntMinnie.com staff writers
Contrast injector technology firm Medrad has received clearance from the U.S. Food and Drug Administration for a wireless MR infusion system.
August 11, 2008
FDA clears BrainLab algorithm
By AuntMinnie.com staff writers
Image-guided therapy firm BrainLab has received 510(k) clearance from the U.S. Food and Drug Administration for its Monte Carlo dose calculation software algorithm.
July 28, 2008
CompuMed to bring OsteoGram to China
By AuntMinnie.com staff writers
Bone density firm CompuMed has received approval from China's State Food and Drug Administration for its OsteoGram bone density screening software.
July 27, 2008
NST is cleared for ApoSense trials
By AuntMinnie.com staff writers
NeuroSurvival Technologies (NST) has received the go-ahead from the U.S. Food and Drug Administration to begin clinical trials of ApoSense.
July 24, 2008
GE gets FDA nod for new PET/CT system
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration clearance for a new PET/CT scanner.
July 23, 2008
GE moves Optison agent through EU regulation
By AuntMinnie.com staff writers
The European Medicines Agency (EMEA) has withdrawn the marketing authorization for GE Healthcare's Optison ultrasound contrast agent, a move that the company said is a routine part of the firm's effort to renew regulatory approval for the product.
July 22, 2008
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