Regulatory: Page 223

Cerner nets clearances
By AuntMinnie.com staff writers
Healthcare information systems firm Cerner has received U.S. Food and Drug Administration 510(k) clearance and the European CE Mark for its ProVision workstation software.
October 7, 2007
AFP wins FDA nod for conebeam CT
By AuntMinnie.com staff writers
Digital x-ray developer AFP Imaging of Elmsford, NY, has received clearance from the U.S. Food and Drug Administration to market its conebeam CT scanner for dental applications, the company reported.
October 4, 2007
Hitachi's Oasis nets FDA OK
By AuntMinnie.com staff writers
Hitachi Medical Systems America of Twinsburg, OH, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Oasis MRI system.
October 1, 2007
Contrast vendors send gadolinium NSF letter
By AuntMinnie.com staff writers
The major manufacturers of gadolinium-based MRI contrast agents have sent a letter to healthcare professionals alerting them to the possible relationship between the agents and nephrogenic systemic fibrosis (NSF).
September 30, 2007
CardioDynamics nets OK for BioZ Dx features
By AuntMinnie.com staff writers
Impedance cardiography (ICG) developer CardioDynamics of San Diego has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance for ICG clinical parameters and the electronic medical record (EMR) interface capability for its BioZ Dx system.
September 27, 2007
Rcadia nets FDA nod
By AuntMinnie.com staff writers
Israeli computer-aided detection (CAD) developer Rcadia Medical Imaging has received a second U.S. Food and Drug Administration (FDA) clearance for its COR Analyzer family of products.
September 25, 2007
Quantum receives FDA OK, Premier pact
By AuntMinnie.com staff writers
Radiology equipment vendor Quantum Medical Imaging of Ronkonkoma, NY, has received clearance from the U.S. Food and Drug Administration (FDA) to market its DiRex digital x-ray system.
September 25, 2007
Cook receives FDA nod for Zenith stent trial
By AuntMinnie.com staff writers
Interventional device firm Cook Medical said it has received U.S. Food and Drug Administration (FDA) clearance to begin a phase I clinical trial for the evaluation of its Zenith Dissection endovascular stent system.
September 23, 2007
IDSI sells HQ for $4.4 million in leaseback deal
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) of Plantation, FL, has sold its headquarters building for $4.4 million in cash pursuant to a sale/leaseback agreement.
September 18, 2007
MR experts take issue with FDA gadolinium warning
By Shalmali Pal
In May 2007, the U.S. Food and Drug Administration (FDA) recommend that a "black box" warning label be places on all gadolinium-based contrast agents. Now a group of MR safety experts have deemed the FDA's suggestion as "imprudent." They argue that the risk of a patient with renal disease developing nephrogenic systemic fibrosis (NSF) does not currently appear to be the same among the various gadolinium-based MR contrast agents.
September 17, 2007
Virtual Imaging wins FDA clearance for FluoroPro
By AuntMinnie.com staff writers
Virtual Imaging of Deerfield Beach, FL, has received clearance from the U.S. Food and Drug Administration (FDA) for its new high-resolution digital acquisition system, FluoroPro.
September 13, 2007
Accuray nets FDA nod for dose calculation tool
By AuntMinnie.com staff writers
Radiotherapy firm Accuray said that its Monte Carlo dose calculation algorithm has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
September 10, 2007
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