CTI (Computerized Thermal Imaging) gets FDA panel review date for thermal imager:
This article was originally published in Clinica
The US FDA's radiological devices panel is scheduled to review on October 16 Computerized Thermal Imaging's (CTI) premarket approval application for its thermal breast imaging system. The BCS 2100 system, which is being assessed by the panel as an adjunct to mammography, uses thermal imaging technology to provide a physiological profile of the breast, rather than the anatomical profile provided by mammograms. The device could provide an accurate and non-invasive way of helping to distinguish between benign and malignant lesions, thereby preventing unnecessary surgical breast biopsies, says the Lake Oswego, Oregon firm, which already has approval to market the system in Europe.