Regulatory: Page 251

Epix submits response to FDA
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has filed a response to the approvable letter it received in January from the Food and Drug Administration for its MS-325 MR blood-pool contrast agent.
May 22, 2005
IDev Longhorn gets FDA nod, enters European market
By AuntMinnie.com staff writers
Interventional radiology, vascular surgery, and cardiology device developer IDev Technologies said the Food and Drug Administration has given marketing clearance for the Texan Longhorn foreign body retrieval device, the latest addition to IDev's Texan product line.
May 17, 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
Conor Medsystems nets CE Mark
By AuntMinnie.com staff writers
Vascular device developer Conor Medsystems has received European CE Mark approval for the use of its UniStar cobalt chromium bare-metal coronary stent for the treatment of de novo coronary artery lesions.
May 9, 2005
Guidant to begin stent trial
By AuntMinnie.com staff writers
Interventional device vendor Guidant has received investigational device exemption (IDE) conditional approval from the Food and Drug Administration to begin the U.S. portion of its Spirit III clinical trial.
May 4, 2005
IDC to bring Xplorer to China
By AuntMinnie.com staff writers
Canadian digital x-ray developer Imaging Dynamics has received clearance from China's State Food and Drug Administration (SFDA) for its Xplorer family of DR systems.
April 27, 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
FDA clearance for IRadimed
By AuntMinnie.com staff writers
MRI infusion-therapy developer IRadimed reported that it has received 510(k) clearance from the Food and Drug Administration for its MRidium MRI infusion pump, a nonmagnetic infusion system designed for MR suites.
April 18, 2005
Nucletron gets FDA OK for OncoSmart Intracavitary
By AuntMinnie.com staff writers
Radiotherapy provider Nucletron has received Food and Drug Administration 510(k) clearance for its OncoSmart Intracavitary applicator set.
April 17, 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
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