In Brief: Siemens/TransScan
This article was originally published in The Gray Sheet
Executive Summary
Siemens/TransScan: Strategic partnership between the firms will include distribution of TransScan Research & Development's TS-2000 non-invasive breast impedance scanner and the joint development of detection devices for other forms of cancer using each firm's proprietary technologies. FDA's Radiological Devices Panel recommended Nov. 17 that a premarket approval application for the TS-2000 system was not approvable because data did not support the use of the device as an adjunct to mammography screening in the clinical setting ("The Gray Sheet" Nov. 24, p. 5)...