Regulatory: Page 262

Medicare set to raise outpatient rates
By AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) is proposing a payment rate update and other policy changes in its annual Outpatient Prospective Payment System (OPPS) rule.
August 9, 2004
Varian adds On-Board Imager features
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for a new suite of features on its On-Board Imager system for the Clinac and Trilogy medical linear accelerators. The new features allow On-Board Imager to synchronize image acquisition with a patient's respiratory cycle and automate "marker matching" for more precise tumor targeting, according to the Palo Alto, CA-based vendor.
August 8, 2004
Siemens launches Magnetom C! scanner
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration 510(k) clearance for Magnetom C!, a 0.35-tesla C-shaped MRI system that offers 270° of accessibility. The system employs a compact magnet with a pole diameter of 54 inches, and is open on three sides, according to the Malvern, PA-based vendor.
August 5, 2004
CHMP recommends SonoVue reinstatement
By AuntMinnie.com staff writers
Europe's Committee for Human Medicinal Products (CHMP) has recommended reinstating the echocardiography indication for Bracco's SonoVue ultrasound contrast agent.
August 4, 2004
Varian gets OK for dose calculator
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for a new dose calculation algorithm based on AAA techniques. The algorithm improves radiation dose distributions in heterogeneous areas of the body such as the lung, where bone, dense soft tissues, and air pockets each interact with radiation in unique ways, Varian said.
August 2, 2004
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
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