CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) in a letter to shareholders today said that it is altering its course for obtaining U.S. Food and Drug Administration premarket approval (PMA) for its CTLM device.
The Plantation, FL-based vendor said that its clinical cases for PMA submission dated back to 2001, and were performed on earlier iterations of the technology. As such, it believes that the studies do not best represent the capabilities of the current device. It said it now intends to collect data using its latest systems because it believes the results will yield a stronger study to support the PMA application.
In other news, IDSI reported that it has sold a CTLM system to its Rome-based distributor Biomedical International for installation at the Hospital Civile di Teramo in Teramo, Italy.
By AuntMinnie.com staff writers
January 27, 2005
Related Reading
Imaging Diagnostic books international orders, January 20, 2005
Imaging Diagnostic nets Turkish distributor, January 4, 2005
Imaging Diagnostic gets CTLM clearance in Canada, November 14, 2003
IDSI PMA judged suitable for filing, June 18, 2003
Imaging Diagnostic Systems receives 12th U.S. patent, May 29, 2003
Copyright © 2005 AuntMinnie.com
