Regulatory: Page 263

Shared PET gets 510(k)
By AuntMinnie.com staff writers
PET services provider Shared PET Imaging has received Food and Drug Administration 510(k) marketing clearance for its ClarityPET software, according to the Canton, OH-based firm.
July 28, 2004
Green light for Agfa mammo workstation
By AuntMinnie.com staff writers
Agfa HealthCare has received Food and Drug Administration clearance for its Impax mammography diagnostic workstation, according to the Greenville, SC-based company.
July 28, 2004
AngioDynamics gets nod for Morpheus
By AuntMinnie.com staff writers
AngioDynamics has received Food and Drug Administration 510(k) clearance for its Morpheus CT peripherally inserted central catheter (PICC).
July 28, 2004
Medicare to ease LOCM restrictions
By AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) is proposing to remove restrictions on payment for low-osmolar contrast materials (LOCM) as part of a program designed to provide new preventive benefits and raise physician payments for 2005.
July 27, 2004
F&S report: European rules stifle innovation
By AuntMinnie.com staff writers
A patchwork of multiple national standards has complicated radiology product and technology innovation in Europe, according to an analysis from market research group Frost & Sullivan.
July 26, 2004
EP MedSystems gets CE Mark
By AuntMinnie.com staff writers
Electrophysiology device developer EP MedSystems has received regulatory approval from the European Notified Body for the integration of Natick, MA-based Boston Scientific's Real-time Position Management (RPM) technology with its EP-WorkMate workstation.
July 26, 2004
FDA promotes Schultz
By AuntMinnie.com staff writers
The Food and Drug Administration (FDA) has named Dr. Daniel Schultz as director of its Center for Devices and Radiological Health (CDRH). Schultz has been acting director of CDRH since April 1, following the resignation of previous director Dr. David Feigal.
July 26, 2004
Siemens gets FDA mobile C-arm OK
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received marketing clearance from the Food and Drug Administration for its Axiom Artis U, a moveable digital C-arm system.
July 21, 2004
Boston Scientific gets FDA nod for Liberte clinical trial
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific of Natick, MA, has received an investigational device exemption from the Food and Drug Administration to begin its ATLAS clinical trial using its Liberte coronary stent as a platform for the firm's paclitaxel-eluting coronary stent system.
July 21, 2004
Stark II interim final rule leaves huge self-referral loophole
By Cherrill Farnsworth
The National Coalition for Quality Diagnostic Imaging Services welcomes the additional flexibility that the U.S. Centers for Medicare and Medicaid Services has brought to the Stark Laws. However, a substantial loophole remains in the statute with regard to the in-office ancillary services exception, according to an editorial by Cherrill Farnsworth.
July 19, 2004
Totoku gets added FDA clearance
By AuntMinnie.com staff writers
Display manufacturer Totoku Electric has received additional Food and Drug Administration 510(k) clearance for its ME511L flat-panel display.
July 18, 2004
ProSolv gets CE Mark
By AuntMinnie.com staff writers
Cardiology digital imaging and reporting software developer Problem Solving Concepts (ProSolv) of Indianapolis said that it has received the European Union's CE Mark for its ProSolv Cardiovascular product.
July 14, 2004
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