Regulatory: Page 222

CMS nets FDA OK for Monaco
By AuntMinnie.com staff writers
Radiation treatment planning firm CMS of St. Louis has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Monaco, its next-generation intensity-modulated radiation therapy (IMRT) planning platform.
October 15, 2007
Definity to carry warning label
By AuntMinnie.com staff writers
At the behest of the U.S. Food and Drug Administration (FDA), Bristol-Myers Squibb Medical Imaging division of North Billerica, MA, will add a warning label to its echocardiography contrast agent Definity.
October 11, 2007
Medtronic's Endeavor moves closer to clearance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has recommended for clearance Medtronic's Endeavor drug-eluting stent for treatment of coronary artery disease, the company reported.
October 10, 2007
FDA clears Pinyons contrast injector
By AuntMinnie.com staff writers
Contrast injector developer Pinyons Medical Technology of Park City, UT, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PowrSyringe injector.
October 10, 2007
Biospace med nets FDA OK on x-ray imager
By AuntMinnie.com staff writers
French digital radiography developer Biospace Med of Paris has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EOS digital x-ray imager for 2D imaging use.
October 8, 2007
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
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