Research map: Artificial intelligence-based software as a medical device: regulatory evolution toward continuous oversight
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Papers in this map
High-performance medicine: the convergence of human and artificial intelligence
· Eric J. Topol · 2018 · 10180 citations · Cited by this paper
When biomarkers for major depressive disorder remain elusive
· 2024 · Related
Development and Validation of a Deep Learning Algorithm for Detection of Diabetic Retinopathy in Retinal Fundus Photographs
· Varun Gulshan · 2016 · 7889 citations · Cited by this paper
Gaseous biomarkers speak medical conditions
· 2026 · Related
Artificial intelligence in healthcare: past, present and future
· Fei Jiang · 2017 · 4885 citations · Cited by this paper
Unfolding ecDNA as a pan-cancer therapeutic target
· 2025 · Related
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· Alvin Rajkomar · 2019 · 4486 citations · Cited by this paper
The AI doctor will see you soon: from assistants to autonomous practitioners
· 2025 · Related
Trust in Automation: Designing for Appropriate Reliance
· John D. Lee · 2004 · 4216 citations · Cited by this paper
Target discovery-directed pharmacological mechanism elucidation of bioactive natural products
· 2025 · Related
Large language models encode clinical knowledge
· Karan Singhal · 2023 · 3892 citations · Cited by this paper
Severe trauma care: advances and future directions in diagnostic and therapeutic techniques and information technology support
· 2026 · Related
Key challenges for delivering clinical impact with artificial intelligence
· Christopher J. Kelly · 2019 · 3052 citations · Cited by this paper
Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care
· 2026 · Related
AI in health and medicine
· Pranav Rajpurkar · 2022 · 2930 citations · Cited by this paper
Proactive personalized early warning systems: the next frontier in climate–health preparedness
· 2026 · Related
Artificial intelligence in healthcare
· Kun‐Hsing Yu · 2018 · 2803 citations · Cited by this paper
Transfer RNA-derived small RNAs (tsRNAs) in Alzheimer’s disease: emerging mechanisms and diagnostic potential
· 2026 · Related
Explainability for artificial intelligence in healthcare: a multidisciplinary perspective
· Julia Amann · 2020 · 2171 citations · Cited by this paper
Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices
· 2026 · Related
Real-World Evidence — What Is It and What Can It Tell Us?
· Rachel E. Sherman · 2016 · 2137 citations · Cited by this paper
Variable generalization performance of a deep learning model to detect pneumonia in chest radiographs: A cross-sectional study
· John R. Zech · 2018 · 1683 citations · Cited by this paper
Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices
· Michael D. Abràmoff · 2018 · 1642 citations · Cited by this paper
Do no harm: a roadmap for responsible machine learning for health care
· Jenna Wiens · 2019 · 1243 citations · Cited by this paper
Artificial intelligence versus clinicians: systematic review of design, reporting standards, and claims of deep learning studies
· Myura Nagendran · 2020 · 1155 citations · Cited by this paper
Recent advances and clinical applications of deep learning in medical image analysis
· Xuxin Chen · 2022 · 1093 citations · Cited by this paper
External Validation of a Widely Implemented Proprietary Sepsis Prediction Model in Hospitalized Patients
· Andrew Hoi‐Tao Wong · 2021 · 972 citations · Cited by this paper
Methodologic Guide for Evaluating Clinical Performance and Effect of Artificial Intelligence Technology for Medical Diagnosis and Prediction
· Seong Ho Park · 2018 · 904 citations · Cited by this paper
Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension
· Xiaoxuan Liu · 2020 · 685 citations · Cited by this paper
A framework for digital health equity
· Safiya I. Richardson · 2022 · 625 citations · Cited by this paper
From patterns to patients: Advances in clinical machine learning for cancer diagnosis, prognosis, and treatment
· Kyle Swanson · 2023 · 607 citations · Cited by this paper
Fairness of artificial intelligence in healthcare: review and recommendations
· Daiju Ueda · 2023 · 591 citations · Cited by this paper
Reporting guideline for the early stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI
· Baptiste Vasey · 2022 · 572 citations · Cited by this paper
Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
· Jennifer C. Goldsack · 2020 · 562 citations · Cited by this paper
AI for radiographic COVID-19 detection selects shortcuts over signal
· Alex J. DeGrave · 2021 · 528 citations · Cited by this paper
How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals
· Eric Qiong Wu · 2021 · 495 citations · Cited by this paper
Artificial intelligence in clinical and genomic diagnostics
· Raquel Dias · 2019 · 467 citations · Cited by this paper
Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension
· Samantha Cruz Rivera · 2020 · 443 citations · Cited by this paper
Automation bias and verification complexity: a systematic review
· David Lyell · 2016 · 429 citations · Cited by this paper
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