Market Access for Radio Equipment in Europe Enabled by the Radio Equipment Directive: Status, Next Steps and Implications

© 1979-2012 IEEE. In Europe, market access for radio equipment is governed through the Radio Equipment Directive (RED), which replaced the Radio Equipment and Telecommunications Terminal Equipment (R&TTE) Directive in 2016. The essential requirements were introduced by RED and subsequently processed by European standards organizations: the European Telecommunications Standards Institute, the European Committee for Electrotechnical Standardization, and the European Committee for Standardization, in order to develop harmonised standards (HSs). These HSs may be used by manufacturers in order to achieve self-declaration of conformity of radio equipment. Compared to the previously applicable R&TTE Directive, RED contains a set of new Articles, including RED Articles 3(3)(a) to 3(3)(i) and Article 4, which were not enacted when RED was originally published. This article discusses the process for "activating" the corresponding articles, and provides commentary on related ongoing activities in European Commission Expert Groups and detailed implications on radio equipment design. Indeed, new requirements need to be met in order to achieve market access, such as reconfigurability, privacy, and security features. Finally, implications such as time to market and RED compliance certification cost are assessed, and a comparison to other regulation regimes is given, including those in the United States, Korea, and Russia

Surgical and oncological long term outcomes of gastrointestinal stromal tumors (GIST) resection- retrospective cohort study

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Prediction of recurrence after surgery in colorectal cancer patients using radiomics from diagnostic contrast-enhanced computed tomography: a two-center study

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Evaluation of KRAS, NRAS and BRAF mutational status and microsatellite instability in early colorectal carcinomas invading the submucosa (pT1): Towards an in-house molecular prognostication for pathologists?

Aim We aimed to study the prognostic value of KRAS, NRAS, BRAF mutations and microsatellite stable (MSS)/instable (MSI) in the field of colorectal cancer invading the submucosa (ie, pT1 colorectal cancer (CRC)). Methods We led a case-control study in tumour samples from 60 patients with pT1 CRC with (20 cases) and without (40 cases) metastatic evolution (5 years of follow-up) which were analysed for KRAS, NRAS, BRAF mutations (Idylla testing and next generation sequencing, NGS) and MSS/MSI status (Idylla testing and expression of mismatch repair (MMR) proteins using immunohistochemistry). Results KRAS mutations were encountered in 11/20 (55%) cases and 21/40 (52.5%) controls (OR=1.11 (0.38 to 3.25), p=0.8548), NRAS mutations in 1/20 (5%) cases and 3/40 (7.5%) controls (OR=3.08 (0.62 to 15.39), p=0.1698) and BRAF mutations in 3/20 (15%) cases and 6/40 (15%) controls (OR=1.00 (0.22 to 4.5), p=1.00). A MSI status was diagnosed in 3/20 (15%) cases and 5/40 (12.5%) controls (OR=1.2353 (0.26 to 5.79), p=0.7885). Beyond the absence of significant association between the metastatic evolution and any of the studied molecular parameters, we observed a very good agreement between methods analysing KRAS, NRAS and BRAF mutations (Kappa value of 0.849 (0.748 to 0.95) between Idylla and NGS) and MSS/MSI (Idylla) -proficient MMR/deficient MMR (immunohistochemistry) status (Kappa value of 1.00). Conclusion Although being feasible using the fully automated Idylla method as well as NGS, the molecular testing of KRAS, NRAS, BRAF and MSS/MSI status does not seem useful for prognostic purpose in the field of pT1 CRC

Hepatic Artery Ligation for Arterial Rupture Following Liver Transplantation: A Reasonable Option

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