IDSI submits Premarket Notification for CTLM breast imaging device to FDA
November 13, 2015
As breast cancer is the most common cancer in women worldwide, the emphasis on breast cancer screening and detection has steadily increased. According to the World Health Organization, survival rates vary widely throughout the world, from more than 80 percent in the United States, Sweden, and Japan, to under 40 percent in poorer countries. In the face of these statistics, along with the benefits that the CTLM system offers to women and their physicians, the system is rapidly gaining international recognition.
Imaging Diagnostic Systems will continue to market the CTLM system and to work with its international clinical sites, where the system has gained approval. The documentation and the data submitted to the FDA will now officially enter the 510(k) review process.
The CTLM system has received certification and licenses European CE marking, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
SOURCE Imaging Diagnostic Systems, Inc.,