FDA: Page 21

NAS nets 510(k)
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) reported that its Nomos radiation oncology division has received 510(k) clearance from the Food and Drug Administration to market nTRAK, a new stereotactic image guidance system used to position and monitor patients during radiation therapy treatments for head and neck cancers.
July 7, 2005
DOBI teams up with Bio-Imaging
By AuntMinnie.com staff writers
Optical breast imaging technology developer DOBI Medical International has entered into a relationship with Bio-Imaging Technologies, which provides medical image management services for clinical trials.
June 8, 2005
Fuji submits PMA for CR mammography
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA of Stamford, CT, has submitted the final module in its premarket approval (PMA) application covering software for conducting computed radiography-based mammography studies.
June 8, 2005
DOBI to add trial sites
By AuntMinnie.com staff writers
Optical breast imaging firm DOBI Medical International of Mahwah, NJ, said it plans to increase the number of U.S. sites participating in the clinical trial of its ComfortScan breast imaging system from 10 to at least 20 sites.
May 31, 2005
EP MedSystems to expand catheter platform
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems of West Berlin, NJ, said it intends to file a request for premarket approval with the Food and Drug Administration for its Alert CS/RA catheter system.
May 30, 2005
Vascular Solutions nets 510(k)
By AuntMinnie.com staff writers
Interventional technology developer Vascular Solutions of Minneapolis has received U.S. Food and Drug Administration 510(k) clearance for the sale of 7-French configurations of its Langston dual-lumen catheter.
May 23, 2005
Breakaway nets O-arm 510(k)
By AuntMinnie.com staff writers
Surgical imaging developer Breakaway Imaging has received Food and Drug Administration 510(k) approval for its mobile O-arm imaging system.
May 12, 2005
DOBI posts Q1 numbers
By AuntMinnie.com staff writers
Optical breast imaging firm DOBI Medical International of Mahwah, NJ, reported fiscal 2005 first-quarter (end-March 31) revenues of $62,000, compared with no revenue in the first quarter of fiscal 2004.
May 9, 2005
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
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