Regulatory: Page 248

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
Barco gets 510(k)
By AuntMinnie.com staff writers
Image display developer Barco of Kortrijk, Belgium, said that it has received Food and Drug Administration 510(k) approval for its MFGD 1218 1-megapixel (MP) flat-panel display for medical viewing.
August 22, 2005
FDA nod for Cook PICC lines
By AuntMinnie.com staff writers
Interventional technology developer Cook said it has received marketing clearance from the Food and Drug Administration for all of its polyurethane Turbo-Flo peripherally inserted central venous catheters (PICC) for use with power injectors for delivery of contrast media in CT studies.
August 22, 2005
Medical Insight brings EasyViz to U.S.
By AuntMinnie.com staff writers
Danish PACS firm Medical Insight has received Food and Drug Administration clearance to market its EasyViz RIS/PACS network.
August 22, 2005
Chiropractic imaging under Medicare attracts attention
By Tracie L. Thompson
Under a new Medicare policy, radiologists in some states can now be reimbursed for CT and MR scans ordered by chiropractors. However, the American College of Radiology (ACR) has raised caution flags over the concept, and imaging centers elsewhere can run into problems if they submit claims for chiropractic-related imaging.
August 22, 2005
RITA gets 510(k)
By AuntMinnie.com staff writers
Oncology device developer RITA Medical Systems has received Food and Drug Administration 510(k) marketing approval for its Habib4X resection device.
August 18, 2005
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