Regulatory: Page 219

CIS-US gets clearance for generic Tc-99m mebrofenin kit
By AuntMinnie.com staff writers
Radiopharmaceutical manufacturer CIS-US has received clearance from the U.S. Food and Drug Administration Office of Generic Drugs to manufacture and market a generic kit for the preparation of technetium-99m (Tc-99m) mebrofenin.
January 29, 2008
Toshiba gets clearance for Titan MRI scanner
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received U.S. Food and Drug Administration clearance for its open-bore 1.5-tesla Vantage Titan MR scanner.
January 27, 2008
Siemens receives FDA nod for Artiste
By AuntMinnie.com staff writers
Siemens Medical Solutions has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Artiste radiation therapy system.
January 23, 2008
ScImage gets FDA nod for digital mammo viewing
By AuntMinnie.com staff writers
PACS vendor ScImage said that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the primary diagnostic review of digital mammography images on its PicomEnterprise PACS offering.
January 22, 2008
FDA extends Cardiolite patent for pediatric use
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has extended the patent on Cardiolite for pediatric applications, effective January 8.
January 21, 2008
BSD Medical posts healthy Q1 results
By AuntMinnie.com staff writers
Brachytherapy and hyperthermia therapy developer BSD Medical of Salt Lake City posted its first-quarter financial results, the company said.
January 9, 2008
GE lays groundwork for resuming surgical C-arm shipments
By Brian Casey
GE Healthcare is getting ready to resume shipments of surgical C-arms, more than a year after voluntarily halting deliveries from its GE OEC Medical Systems unit as part of a consent decree with the U.S. Food and Drug Administration (FDA). The company is completing the final steps required by the FDA to meet the agency's concerns over good manufacturing practices at its OEC facilities.
January 6, 2008
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NordicNeuroLab wins clearance for fMRI system
By AuntMinnie.com staff writers
NordicNeuroLab (NNL) of Bergen, Norway, has received clearance from the U.S. Food and Drug Administration for its fMRI Hardware System, the company reported.
January 3, 2008
MedX scores clearance for T-Quest
By AuntMinnie.com staff writers
Nuclear medicine developer MedX has received U.S. Food and Drug Administration 510(k) clearance for its T-Quest gamma camera.
January 2, 2008
Breast imaging start-up gets FDA OK for software
By AuntMinnie.com staff writers
Breast imaging software developer Three Palm Software has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its WorkstationOne breast imaging workstation.
January 2, 2008
Ultrasound contrast advocates take aim at FDA black box warning
By Cynthia E. Keen
Advocates of ultrasound contrast have launched a grassroots lobbying effort to persuade the U.S. Food and Drug Administration (FDA) to relax its recent black box warning on the use of two echocardiography contrast agents. The group believes the FDA warning was unnecessarily strident given the safety profile of ultrasound contrast, and that the warning could hamstring further clinical use of cardiac ultrasound contrast.
January 2, 2008
Varian nets FDA nod
By AuntMinnie.com staff writers
Radiation therapy vendor Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RapidArc radiotherapy technology.
January 1, 2008
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