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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: szymanski p. 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.
Implementing the new European Regulations on medical devices-clinical responsibilities for evidence-based practice: a report from the Regulatory Affairs Committee of the European Society of Cardiology.
Fraser AG, Byrne RA, Kautzner J, Butchart EG, Szymański P, Leggeri I, de Boer RA, Caiani EG, Van de Werf F, Vardas PE, Badimon L. Fraser AG, et al. Among authors: szymanski p. Eur Heart J. 2020 Jul 14;41(27):2589-2596. doi: 10.1093/eurheartj/ehaa382. Eur Heart J. 2020. PMID: 32484542
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P; CORE–MD Investigators (see Appendix). Fraser AG, et al. Among authors: szymanski p. EFORT Open Rev. 2021 Oct 19;6(10):839-849. doi: 10.1302/2058-5241.6.210081. eCollection 2021 Oct. EFORT Open Rev. 2021. PMID: 34760284 Free PMC article. Review.
Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szymański P, Melvin T, Piscoi P; CORE-MD Investigators. Fraser AG, et al. Among authors: szymanski p. Eur Heart J Qual Care Clin Outcomes. 2022 May 5;8(3):249-258. doi: 10.1093/ehjqcco/qcab059. Eur Heart J Qual Care Clin Outcomes. 2022. PMID: 34448829 Free PMC article.
395 results