FDA: Page 24

Elekta’s Synergy receives 510(k)
By AuntMinnie.com staff writers
Swedish radiation therapy firm Elekta has received Food and Drug Administration 510(k) clearance for its Synergy radiation therapy platform.
October 27, 2003
EP MedSystems receives 510(k) for ViewMate
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems has received Food and Drug Administration 510(k) clearance for its ViewMate intracardiac ultrasound catheter imaging system.
October 22, 2003
CMS gets 510(k) for I-Beam
By AuntMinnie.com staff writers
Radiation therapy software provider CMS has received Food and Drug Administration 510(k) clearance for I-Beam, a mobile patient positioning system that employs ultrasound and other images to confirm the location of target organs or tumors.
October 20, 2003
Aurora gets 510(k) for RODEO breast imaging
By AuntMinnie.com staff writers
Breast MRI developer Aurora Imaging Technology of North Andover, MA, has received U.S. Food and Drug Administration 510(k) marketing clearance for its rotating delivery of excitation off-resonance (RODEO) breast imaging method.
September 25, 2003
Cardinal Health gets 510(k), NVLAP accreditation
By AuntMinnie.com staff writers
Healthcare firm Cardinal Health of Dublin, OH, said its Nuclear Associates subsidiary has received U. S. Food and Drug Administration 510(k) clearance for its CalRad Mark VI Dose Calibrator.
September 24, 2003
OrthoView receives 510(k) clearance
By AuntMinnie.com staff writers
Medical applications developer Meridian Technique of Hampshire, U.K., has received U.S. Food and Drug Administration 510(k) pre-market clearance for its OrthoView digital templating software.
September 22, 2003
FDA sets date to review Boston Scientific stent
By AuntMinnie.com staff writers
The Food and Drug Administration will hold a special panel hearing on November 20 to review Boston Scientific’s premarket approval (PMA) application for the Taxus Express2 paclitaxel-eluting coronary stent.
September 15, 2003
Henry Schein divests PMA Bode
By AuntMinnie.com staff writers
Healthcare products and services provider Henry Schein of Melville, NY, has entered into an agreement to divest its PMA Bode business.
September 1, 2003
Aurora receives 510(k) for increased field strength
By AuntMinnie.com staff writers
Breast MRI developer Aurora Imaging Technology of North Andover, MA, has received Food and Drug Administration 510(k) marketing clearance for a new, 1.5-tesla version of its dedicated breast MRI scanner.
August 6, 2003
EP MedSystems seeks 510(k) for integrated system
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems has requested a 510(k) regulatory clearance filing with the Food and Drug Administration for the integration of its WorkMate intracardiac ultrasound catheter system with Boston Scientific’s Realtime Position Management technology.
July 23, 2003
Varian releases planning software, receives 510(k)
By AuntMinnie.com staff writers
X-ray and radiation therapy developer Varian Medical Systems of Palo Alto, CA, has released the latest iteration of its Eclipse 3-D radiotherapy treatment-planning software for image-guided radiotherapy.
July 17, 2003
Varian gets 510(k) for VariSeed 7.1
By AuntMinnie.com staff writers
X-ray and radiation therapy developer Varian Medical Systems has received Food and Drug Administration 510(k) marketing clearance for the 7.1 iteration of VariSeed.
June 4, 2003
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