Published on in Vol 25 (2023)
Preprints (earlier versions) of this paper are
available at
https://preprints.jmir.org/preprint/47505, first published
.
Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis
Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis
Journals
- Weimar S, Martjan R, Terzidis O. Conceptualizing the landscape of digital health entrepreneurship: a systematic review and research agenda. Management Review Quarterly 2025;75(2):1619 View
- Yew S, Trivedi D, Adanan N, Chew B. Facilitators and Barriers to the Implementation of Digital Health Technologies in Hospital Settings in Lower- and Middle-Income Countries Since the Onset of the COVID-19 Pandemic: Scoping Review. Journal of Medical Internet Research 2025;27:e63482 View
- Francesconi M, Cangi M, Tamarri S, Conditi N, Menicucci C, Ravizza A, Cattaneo L, Bianchini E. Navigating regulatory challenges across the life cycle of a SaMD. Journal of Biomedical Informatics 2025;167:104856 View
- Singh V, Cheng S, Kwan A, Ebinger J. United States Food and Drug Administration Regulation of Clinical Software in the Era of Artificial Intelligence and Machine Learning. Mayo Clinic Proceedings: Digital Health 2025;3(3):100231 View
- Martjan R, Weimar S, Terzidis O. A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of Medical Internet Research 2025;27:e67328 View
- Kamil Jabłoński , Aleksandra Grygorowicz , Klaudia Baran , Michał Ględa , Michał Szyszka , Weronika Radecka , Weronika Kozak , Agnieszka Szreiber , Karol Grela , Karolina Nowacka , Anna Woźniak . INTERVENTIONAL CARDIOLOGY: AN OVERVIEW OF CURRENT APPLICATIONS, CHALLENGES, AND FUTURE PATHWAYS – THE ERA OF AI-ASSISTED PCI?. International Journal of Innovative Technologies in Social Science 2025;2(4(48)) View
- Goto R, Sengoku S, Kodama K. Programmed Medical Device (SaMD) and Orphan Drug Innovation Processes and Industrial Systems. YAKUGAKU ZASSHI 2026;146(1):35 View
- Schilder M, Keyser A, van Hees S, Sbrizzi A, Boon W. Anticipating Moral and Economic Considerations, Opportunities, and Potential Frictions for AI in Medical Imaging: Multistakeholder Cocreation Study. Journal of Medical Internet Research 2026;28:e83407 View
- Wang R, Ding X, Zhang W, Shi T. The transformative potential of artificial intelligence in pediatric medicine: Current applications, methodological challenges, and future directions. Pediatric Investigation 2026;10(4):345 View
- Yu J, Zhang J, Miyashita S, Sengoku S. Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products. DIGITAL HEALTH 2026;12 View
- Kim E, Park H, Shinn J, Kim H. From Prediction to Prognosis: Artificial Intelligence Redefining the Care Lifecycle in Cardiometabolic Syndrome. CardioMetabolic Syndrome Journal 2026;6(2):212 View
- Tan C, Ng E, Eydelman M, Wirostko B, Stagg B. What Does the US Food and Drug Administration Regulation of Portable Perimeters Mean?. Ophthalmology Glaucoma 2026 View
- Lee Y, Youn B. Clinical Specialty Expansion of AI-Enabled and Machine Learning–Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysis. Journal of Medical Internet Research 2026;28:e103040 View
Books/Policy Documents
- Klüglich M. Global Bioethics - Current Challenges, New Developments, and Future Directions. View
- Chaiya N, Tangkuaram T, Moonla C. Nano-bioelectronics for Precision Health Monitoring. View
- Atti H, Porika S, Sreepada D, Rayilla D, Samudrala M, Raju R, Andy A, Budhewar A, Dwivedi A, Singh A. Revolutionizing Drug Research and Personalized Medicine Through AI and Machine Learning. View
- Greenwood J, Qian R. New Perspectives on Post-2020 Healthcare Reform. View