The submission of the pre-investigational device exemption document was made by Schiff & Co., a firm specializing in international regulatory affairs, compliance and clinical research.
“The meeting with the FDA has a purpose of determining any additional information required for submission of the IDE and to determine the acceptability of the clinical protocol and establish the initial clinical efficacy of the CD-Ratiometer,” said President and Chief Operating Officer Michael Engelhart.
Carcinogenesis is accompanied by molecular and structural changes in tissue. These changes affect the absorption, scattering and fluorescence properties of the tissue, and hence provide a method to spectroscopically distinguish malignant and pre-malignant tissue for normal or benign tissue.
Mediscience Technology is focused on the development of medical devices that detect cancer and physiological change using frequencies of light that are emitted, scattered and absorbed to distinguish malignant, pre-cancerous or benign tissues from normal tissues.