Accelerating digital innovation in clinical neuropsychology: simulation approach to support medical device certification
Certification of digital solutions as SaMD may require costly and time-consuming validation procedures. Simulation-based approach based on synthetic data is a valid method to overcome this limitation, that can be easily implemented to test platform, accelerating innovation in teleneuropsychology and providing adequate evidence of safety, efficacy and long-term comparability with the standard of care.
Authors
- Roberta Pandolfi
- Luigi Trojano (ORCID: https://orcid.org/0000-0002-0328-9642)
- S. F. Cappa
- C Papagno
- Tiziana Iaquinta
- FEDERICA L’ABBATE
- Dalila De Vita (ORCID: https://orcid.org/0000-0002-3372-4035)
- Sveva Sanzone
- Monica Calore
- Alice Ravizza
- Marra Camillo
- Alessandra Dodich
- Chiara Cerami
- Luigi Lavorgna
- Federico Sternini
- Cristina Fonti
- Valentina Laganà
- Andrea Panzavolta
- Francesca Ferrari Pellegrini
- Andrea Stracciari
- Paolo Caffarra
Institutions
- Università Cattolica del Sacro Cuore (IT)
- Leonardo (United States) (US)
- Politecnico di Torino (IT)
- University of Trento (IT)
- University of Campania "Luigi Vanvitelli" (IT)
- Istituto Universitario di Studi Superiori di Pavia (IT)
- Ministero della Salute (IT)
- Agostino Gemelli University Polyclinic (IT)
- Istituti Clinici Scientifici Maugeri (IT)
- Istituto Nazionale di Documentazione Innovazione e Ricerca Educativa (IT)
- Istituto delle Scienze Neurologiche di Bologna (IT)
- Azienda Ospedaliera Universitaria Università degli Studi della Campania Luigi Vanvitelli (IT)
- IRCCS Istituto Auxologico Italiano (IT)
- Tokyo Metropolitan Geriatric Hospital (JP)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Biogen (Italy) (IT)
Publication Details
- Journal
- Frontiers in Digital Health
- Published
- 2026-02-12
- DOI
- https://doi.org/10.3389/fdgth.2025.1646694
- Primary Topic
- EEG and Brain-Computer Interfaces
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Biogen