First FDA submission for laser mammography device:
This article was originally published in Clinica
Executive Summary
Imaging Diagnostic Systems has submitted to the US FDA the first part of its modular PMA application for its laser-based technology for breast imaging, the CT laser mammography (CTLM) system. The Fort Lauderdale, Florida-based company is seeking FDA approval to use the CTLM as an adjunctive diagnostic test to the mammogram and clinical examination for the detection of breast anomalies.