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European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.
Guerlich K, Patro-Golab B, Barnacle A, Baumann U, Eicken A, Fraser AG, Gruszfeld D, Haas NA, Jonker AH, Kammermeier M, Kenny D, Kolaček S, Lapatto R, Maconochie I, Mader S, McGauran G, Melvin T, Muensterer O, Piscoi P, Romano A, Saxena AK, Schneider DT, Turner MA, Walle JV, Koletzko B; European Academy of Paediatrics. Guerlich K, et al. Among authors: fraser ag. Acta Paediatr. 2023 Nov;112(11):2440-2448. doi: 10.1111/apa.16919. Epub 2023 Aug 15. Acta Paediatr. 2023. PMID: 37485905
Clinical evidence for high-risk CE-marked medical devices for glucose management: A systematic review and meta-analysis.
Bano A, Künzler J, Wehrli F, Kastrati L, Rivero T, Llane A, Valz Gris A, Fraser AG, Stettler C, Hovorka R, Laimer M, Bally L; CORE‐MD investigators. Bano A, et al. Among authors: fraser ag. Diabetes Obes Metab. 2024 Oct;26(10):4753-4766. doi: 10.1111/dom.15849. Epub 2024 Aug 14. Diabetes Obes Metab. 2024. PMID: 39143655 Free article.
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.
Hoogervorst LA, Geurkink TH, Lübbeke A, Buccheri S, Schoones JW, Torre M, Laricchiuta P, Piscoi P, Pedersen AB, Gale CP, Smith JA, Maggioni AP, James S, Fraser AG, Nelissen RGHH, Marang-van de Mheen PJ. Hoogervorst LA, et al. Among authors: fraser ag. Int J Health Policy Manag. 2023;12:7648. doi: 10.34172/ijhpm.2023.7648. Epub 2023 Jul 18. Int J Health Policy Manag. 2023. PMID: 37579359 Free PMC article.
Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.
Hoogervorst LA, Ren Y, Melvin T, Stratton-Powell AA, Lübbeke A, Geertsma RE, Fraser AG, Nelissen RGHH, Caiani EG, Marang-van de Mheen PJ. Hoogervorst LA, et al. Among authors: fraser ag. Acta Orthop. 2024 Nov 25;95:667-676. doi: 10.2340/17453674.2024.42361. Acta Orthop. 2024. PMID: 39584822 Free PMC article.
Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).
Wilkinson C, Bhatty A, Batra G, Aktaa S, Smith AB, Dwight J, Ruciński M, Chappell S, Alfredsson J, Erlinge D, Ferreira J, Guðmundsdóttir IJ, Hrafnkelsdóttir ÞJ, Ingimarsdóttir IJ, Irs A, Jánosi A, Járai Z, Oliveira-Santos M, Popescu BA, Vasko P, Vinereanu D, Yap J, Bugiardini R, Cenko E, Nadarajah R, Sydes MR, James S, Maggioni AP, Wallentin L, Casadei B, Gale CP; Global Cardiovascular Outcomes Consortium and in collaboration with ACNAP, ACVC, EACVI, EAPC, EAPCI, EHRA, ESC Committee for Young CV Professionals, ESC Registry Committee, HFA, ESC Patient Forum and these Working Groups: aorta and peripheral vascular diseases, atherosclerosis and vascular biology, cardiac cellular electrophysiology, cardiovascular pharmacotherapy, cardiovascular regenerative and restorative medicine, cardiovascular surgery, cellular biology of the heart, e-cardiology, myocardial function, pulmonary circulation and right ventricular function and thrombosis. Wilkinson C, et al. Eur Heart J. 2025 Jan 7;46(2):190-214. doi: 10.1093/eurheartj/ehae724. Eur Heart J. 2025. PMID: 39545867 Free PMC article.
Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).
Caiani EG, Kemps H, Hoogendoorn P, Asteggiano R, Böhm A, Borregaard B, Boriani G, Brunner La Rocca HP, Casado-Arroyo R, Castelletti S, Christodorescu RM, Cowie MR, Dendale P, Dunn F, Fraser AG, Lane DA, Locati ET, Małaczyńska-Rajpold K, Merșa CO, Neubeck L, Parati G, Plummer C, Rosano G, Scherrenberg M, Smirthwaite A, Szymanski P. Caiani EG, et al. Among authors: fraser ag. Eur Heart J Digit Health. 2024 Jun 4;5(5):509-523. doi: 10.1093/ehjdh/ztae042. eCollection 2024 Sep. Eur Heart J Digit Health. 2024. PMID: 39318699 Free PMC article.
394 results