Regulatory: Page 252

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
Heartlab nets CE Mark
By AuntMinnie.com staff writers
Cardiac image management firm Heartlab has secured the CE Mark for its entire class of products.
April 12, 2005
CMS provides details on new PET coverage
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) released two transmittals on April 1 that update the PET national coverage determination (NCD) for the new cervical cancer coverage guidelines, describe the agency's PET registry project, and explain the coding and billing instructions for the new current procedural terminology (CPT) codes.
April 7, 2005
Abbott gets FDA OK for ZoMaxx trial
By AuntMinnie.com staff writers
Interventional device developer Abbott Laboratories of Abbott Park, IL, said it has received conditional approval from the Food and Drug Administration for an investigational device exemption (IDE) application for the ZoMaxx drug-eluting stent.
April 6, 2005
E-Z-EM scores patent for NutraPrep
By AuntMinnie.com staff writers
Contrast and virtual colonoscopy developer E-Z-EM has received a patent from the U.S. Patent and Trademark Office for its NutraPrep preprocedure meal plan for virtual and optical colonoscopy.
April 6, 2005
Boston Scientific adds CE Mark
By AuntMinnie.com staff writers
Interventional device manufacturer Boston Scientific has received the European CE Mark for three large vessel sizes of its Taxus Express2 paclitaxel-eluting coronary stent system.
April 5, 2005
Boston Scientific gets FDA OK for Taxus in MRI
By AuntMinnie.com staff writers
Interventional device manufacturer Boston Scientific reported that the Food and Drug Administration has approved enhancements to the directions for use (DFU) of its Taxus Express2 paclitaxel-eluting coronary stent system, indicating that patients receiving the stent systems may safely undergo an MRI immediately following implantation.
April 4, 2005
Longport to delay filing 2004 results
By AuntMinnie.com staff writers
Ultrasound technology developer Longport has filed with the Securities and Exchange Commission for a deadline extension for filing its Form 10-QSB.
March 31, 2005
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