Regulatory: Page 252

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
DMS nets FDA nod
By AuntMinnie.com staff writers
Chinese joint venture Direct Medical Systems has received Food and Drug Administration clearance to market its DMS-C800 CT scanner and DMS-880P portable black-and-white ultrasound system in the U.S.
April 14, 2005
Boston Scientific gets FDA approval for Liberté stent
By AuntMinnie.com staff writers
Interventional device manufacturer Boston Scientific said that it has received Food and Drug Administration approval for its Liberté bare-metal coronary stent system.
April 13, 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
Given gets German reimbursement nod
By AuntMinnie.com staff writers
Video-capsule manufacturer Given Imaging of Yoqneam, Israel, reported that the central consultation committee for reimbursement issues of Germany's Federal Chamber of Physicians has approved reimbursement for capsule endoscopy for obscure gastrointestinal bleeding following inconclusive upper and lower endoscopy.
April 12, 2005
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