Food and Drug Administration.

‘We’re being extremely methodical in bringing this technology to the clinic, while ensuring that the gear meets the laboratories’ requires.’ The Infinity Series1200 is stated in Waldbronn, Germany, and the 6000 Series is stated in Singapore. Both facilities are authorized as medical device establishments with the FDA, a requirement of manufacturing medical gadgets. In September 2011, those facilities were authorized as meeting the internationally recognized ISO 13485 quality-management standard.The accelerated-fractionation radiotherapy consisted of the delivery of 72 Gy in 42 fractions over a 6-week period, with a concomitant increase of twice-daily irradiation for 12 treatment times , and standard-fractionation radiotherapy consisted of the delivery of 70 Gy in 35 fractions over a 7-week period. Intravenous cisplatin was administered at a dose of 100 mg per square meter of body-surface area on times 1 and 22 in the accelerated-fractionation radiotherapy group and on times 1, 22, and 43 in the standard-fractionation radiotherapy group. Acute toxicity was evaluated weekly over therapy according to the Common Terminology Criteria, version 2.0 visualized with use of an autostainer and a one-view secondary detection kit .12 Positive p16 expression was defined as strong and diffuse nuclear and cytoplasmic staining in 70 percent or more of the tumor cells.12 Study End Factors The principal end point was overall survival, defined as enough time from randomization to loss of life.