Robodoc to enter Japanese trials:
This article was originally published in Clinica
Executive Summary
Integrated Surgical Systems (ISS) has moved a step closer to Japanese approval of its Robodoc Surgical Assistant System with approval from the Ministry of Health and Welfare to begin clinical trials in Japan. Japan is expected to be a substantial market for the Robodoc system, according to ISS' distributor, Imatron Japan, partly on the grounds that Japan has more CT and MRI systems than the US. The system is already marketed elsewhere, with 37 systems currently installed worldwide. The Japanese studies will assess up to 60 patients with a short follow-up period, and will involve the implantation of Zimmer's VerSys line of hip stem prostheses. Davis, California-based ISS said the trials could be completed by year-end, with approval forthcoming in the first half of 2001.