AI-Based Medical Devices and Regulations: A Cross-Country Perspective

Author:

Sharma KavitaORCID,Manchikanti Padmavati

Publisher

Springer Nature Singapore

Reference26 articles.

1. 510(k) Submission Programs (FDA) (2019) https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-programs. Accessed 17 Sept 2022.

2. About Vicarious Surgical | Revolutionizing Robotic Surgery (Vicarious Surgical) (2022) https://www.vicarioussurgical.com/about. Accessed 17 Dec 2022

3. Aerts A, Bogdan-Martin D (2021) Leveraging data and AI to deliver on the promise of digital health. Int J Med Inform 150(104456):1–6

4. Artificial Intelligence and Machine Learning in Software (FDA) (2021) https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device. Accessed 30 Oct 2022

5. Benjamens S, Dhunnoo P, Meskó B (2020) The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database. NPJ Dig Med 3. https://doi.org/10.1038/s41746-020-00324-0

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