Dec. 6 – Imaging Diagnostic Systems (IDSI), a laser optical breast imaging company, has secured its tenth U.S. clinical site to participate in its CT laser mammography (CTLM) clinical trials. Under regulatory protocol, the sites are collecting patient studies for the submission of a pre-market approval (PMA) application to the FDA.
Deborah O’Brien, IDSI senior vice president, said that even though the company has performed many CTLM breast exams internationally, “we have elected to utilize only those cases collected in the U.S. under our approved PMA clinical trials protocol. We may also include two additional U.S. clinical sites to further shorten the time needed to collect the prescribed number of confirmed cancer and non-cancer cases to be used for the statistical analysis as a major component of our PMA application.”
“Upon completion of the data collection phase, we will conduct an image interpretation or reading phase where CTLM scans and conventional mammography exams will be read adjunctively by specially trained radiologists. That data, along with confirmed biopsy results, will then be analyzed according to our primary and secondary intended uses by an outside biostatistical firm” O’Brien said. Unlike IDSI’s prior PMA application, the new PMA application will not be submitted in the modular form, although IDSI will use the previous work in preparing the new single PMA filing.”
The Fort Lauderdale, Fla.-based IDSI added that the FDA may also require a panel of experts to review the findings for its final recommendation.
The CTLM system has completed registrations including the CE Mark, CMDCAS Canadian License, China SFDA and FDA export certification, IDSI said.