Regulatory: Page 220

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

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