FDA: Page 21

Misonix files 510(k) for ultrasonic wound debrider
By AuntMinnie.com staff writers
Ultrasound developer Misonix of Farmingdale, NY, has filed a 510(k) application with the Food and Drug Administration (FDA) for clearance to market its ultrasonic wound debridement system.
April 20, 2005
iCAD files for 510(k)
By AuntMinnie.com staff writers
Computer-aided detection developer iCAD has submitted a 510(k) application to the Food and Drug Administration for its first lung cancer detection-support offering.
April 17, 2005
Additional 510(k) for Medx computer
By AuntMinnie.com staff writers
Gamma camera refurbishing firm Medx has received an additional Food and Drug Administration 510(k) clearance for its NuQuest computer.
April 14, 2005
Medtronic begins Endeavor IV trial
By AuntMinnie.com staff writers
Medical device developer Medtronic said that enrollment has begun in its Endeavor IV clinical trial, the final phase of its Endeavor clinical program to be used in support of a Food and Drug Administration premarket approval (PMA) application.
April 12, 2005
Abbott submits StarClose PMA
By AuntMinnie.com staff writers
Interventional device developer Abbott Vascular Devices (AVD), a subsidiary of Abbott Laboratories of Abbott Park, IL, said it has submitted an application for premarket approval (PMA) for its StarClose vascular closure system to the Food and Drug Administration.
April 12, 2005
DOBI reports year-end results
By AuntMinnie.com staff writers
Optical breast imaging developer DOBI Medical International of Mahwah, NJ, reported financial results for fiscal 2004 that show the development-stage company beginning to generate revenue for the first time.
March 13, 2005
RADIN gets 510(k) for PACS
By AuntMinnie.com staff writers
German PACS software developer RADIN has received 510(k) clearance from the U.S. Food and Drug Administration for its RADIN PACS software.
March 9, 2005
FDA denies Biofield regulatory request
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has turned down an appeal from breast technology developer Biofield that would have made it easier for the Atlanta-based company to get its flagship product through the regulatory approval process.
March 8, 2005
Elekta Beam Modulator gets 510(k) nod
By AuntMinnie.com staff writers
Radiation therapy provider Elekta has received U.S. Food and Drug Administration 510(k) marketing clearance for its Elekta Beam Modulator, a multileaf collimator designed for use with its medical linear accelerators.
February 23, 2005
McKesson gets workstation 510(k)
By AuntMinnie.com staff writers
McKesson Information Solutions - Medical Imaging Group said that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its Horizon Rad Station release 11.0 PACS workstation for reading, distributing, and storing full-field digital mammography (FFDM) images.
February 10, 2005
Barco wins 510(k) for VesselMetrix
By AuntMinnie.com staff writers
Barco of Kortrijk, Belgium, has received 510(k) clearance from the U.S. Food and Drug Administration for Voxar 3D VesselMetrix.
February 7, 2005
CSI gets 510(k), European trial approval
By AuntMinnie.com staff writers
Interventional device developer Cardiovascular Systems (CSI) of Minneapolis has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its orbital atherectomy device to remove tissue-causing stenosis in synthetic AV shunts.
February 2, 2005
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