Regulatory: Page 247

FDA issues draft CGMP for PET radiopharmaceuticals
By AuntMinnie.com staff writers
The Food and Drug Administration has drafted a current good manufacturing practices (CGMP) regulation for the production of pharmaceuticals used in PET imaging, the agency reported.
September 25, 2005
Kodak gets nod for mammo CAD upgrades
By AuntMinnie.com staff writers
Eastman Kodak Health Group has received Food and Drug Administration clearance for enhancements to its computer-aided detection (CAD) system.
September 20, 2005
FDA approves Abbott carotid stent
By AuntMinnie.com staff writers
The Food and Drug Administration has approved a carotid stent from Abbott Laboratories that's designed to be a minimally invasive treatment for patients with carotid artery disease.
September 15, 2005
FDA posts guidance for mammo centers hit by Katrina
By AuntMinnie.com staff writers
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has issued guidelines on how to manage mammography programs in the wake of a natural disaster, such as Hurricane Katrina.
September 8, 2005
Boston Scientific gets Taxus CE Mark
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said it has received the European CE Mark for its Taxus Liberté paclitaxel-eluting stent system.
September 7, 2005
GE gets Innova CT clearance
By AuntMinnie.com staff writers
Multimodality vendor GE Healthcare of Chalfont St. Giles, U.K., has received Food and Drug Administration clearance for Innova CT, a new technique that enables the creation of 3D images on the company's Innova 3100 and 4100 angiography systems.
September 6, 2005
CompuMed gets CE Mark
By AuntMinnie.com staff writers
Medical informatics firm CompuMed of Los Angeles has received the European CE Mark for its OsteoGram system.
September 6, 2005
MDX gets clearance for PACS/RIS
By AuntMinnie.com staff writers
PACS developer MDX of Oakville, Ontario, has received Food and Drug Administration for its Insight PACS/RIS software.
August 30, 2005
CMS seeks to rein in nuclear medicine self-referral
By Jonathan S. Batchelor
The growth of nuclear medicine services in recent years has attracted the notice of the U.S. Centers for Medicare and Medicaid Services (CMS). This month, CMS proposed a rule barring physician self-referral for nuclear medicine procedures, raising more questions than answers.
August 30, 2005
CMS approves VC after failed colonoscopy in Midwest
By Eric Barnes
Beginning October 16, Medicare in four Midwestern states will pay for a virtual colonoscopy (CT colonography) exam after diagnostic colonoscopy fails for any reason. The local coverage decision also authorizes an initial VC examination for two indications without the need for initial failed colonoscopy.
August 29, 2005
J&J, Guidant merger gets European clearance
By AuntMinnie.com staff writers
The merger of interventional device vendor Guidant of Indianapolis with healthcare products manufacturer Johnson & Johnson of New Brunswick, NJ, has been cleared by the European Commission, the firms reported.
August 24, 2005
FDA warns Boston Scientific
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, was warned by the Food and Drug Administration about regulatory problems with its medical devices, including the firm's Taxus coronary artery stent.
August 23, 2005
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