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Bakul Patel
标题
引用次数
引用次数
年份
Proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD)
Food and Drug Administration
Department of Health and Human Services (United States), 2019
3722019
Using digital health technology to better generate evidence and deliver evidence-based care
A Sharma, RA Harrington, MB McClellan, MP Turakhia, ZJ Eapen, ...
Journal of the American College of Cardiology 71 (23), 2680-2690, 2018
3052018
FDA regulation of mobile medical apps
J Shuren, B Patel, S Gottlieb
Jama 320 (4), 337-338, 2018
1482018
Digital biomarkers: convergence of digital health technologies and biomarkers
S Vasudevan, A Saha, ME Tarver, B Patel
NPJ digital medicine 5 (1), 36, 2022
892022
Proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD): discussion paper and request for …
US FDA
US Food Drug Adm, 1-20, 2019
702019
Foundational considerations for artificial intelligence using ophthalmic images
MD Abràmoff, B Cunningham, B Patel, MB Eydelman, T Leng, ...
Ophthalmology 129 (2), e14-e32, 2022
522022
Advancing digital health: FDA innovation during COVID-19
K Kadakia, B Patel, A Shah
Npj Digital Medicine 3 (1), 161, 2020
512020
Software as a medical device (SaMD)
US Food and Drug Administration
Clinical, 2022
472022
based Software as a Medical Device (SaMD) action plan
A Intelligence, M Learning
Food and Drug Administration, 2021-06, 2021
422021
Software as a medical device (SaMD): key definitions
IMDRF SaMD Working Group
International Medical Device Regulators Forum, 1-9, 2013
422013
General wellness: Policy for low risk devices
US Food and Drug Administration
Fed. Reg 81, 49993-49995, 2016
352016
Software as a medical device (SAMD): clinical evaluation–guidance for industry and Food and Drug Administration staff
US Food and Drug Administration
FDA: Silver Spring, MD, 2017
232017
Software as a medical device”: possible framework for risk categorization and corresponding considerations
IMDRF SaMD Working Group
International Medical Device Regulators Forum, 2014
222014
Remote digital monitoring for medical product development
ES Izmailova, JA Wagner, N Ammour, N Amondikar, A Bell‐Vlasov, ...
Clinical and translational science 14 (1), 94-101, 2021
182021
Software as a medical device (SaMD): clinical evaluation
IMDRF SaMD Working Group
Int Med Device Regul Forum, 4-8, 2017
152017
Recent advances in systems and network medicine: meeting report from the first international conference in systems and network medicine
E Kurnat-Thoma, A Baranova, P Baird, E Brodsky, AJ Butte, AK Cheema, ...
Systems Medicine 3 (1), 22-35, 2020
122020
FDASIA health IT report: Proposed strategy and recommendations for a risk-based framework
US Food and Drug Administration
Washington, DC: US Food and Drug Administration, 2014
92014
Collaborative Community on Ophthalmic Imaging Executive Committee and Foundational Principles of Ophthalmic Imaging and Algorithmic Interpretation Working Group. Foundational …
MD Abràmoff, B Cunningham, B Patel, MB Eydelman, T Leng, ...
Ophthalmology 129 (2), e14-32, 2022
82022
Digital biomarkers: convergence of digital health technologies and biomarkers. NPJ Digital Medicine, 5 (1), 36
S Vasudevan, A Saha, ME Tarver, B Patel
Number 1, 1-3, 2022
72022
IMDRF
WG SaMD
62013
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