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Synapse
February 26, 20260 citationsOpen Access

US Experience: FDA-Approved AI Devices – 1,200+ Authorizations, Critical Evidence Gaps

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OIOleh IvchenkoDGDmytro Grybeniuk Dmytro Grybeniuk

Key Points

  • The aim is to examine the landscape of FDA-approved AI devices and identify critical evidence gaps.
  • Data analysis of over 1,200 authorized AI devices
  • Review of regulatory documentation and guidelines
  • Assessment of reported evidence supporting device efficacy
  • Identified numerous critical gaps in supporting evidence for safety and effectiveness
  • Highlighted inconsistencies in the regulatory framework for AI device authorizations
  • Demonstrated a rapid increase in the number of AI device approvals over recent years

Abstract

Research article from Stabilarity Research Hub: US Experience: FDA-Approved AI Devices – 1,200+ Authorizations, Critical Evidence Gaps

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Cite This Study

Ivchenko et al. (2026) studied this question.

synapsesocial.com/papers/699fe33695ddcd3a253e6eb5https://doi.org/10.5281/zenodo.18752892
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Also Consider

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  1. 1Artificial intelligence in urology: A review of United States Food and Drug Administration‐cleared devices2026
  2. 2Three Decades of Food and Drug Administration Authorizations of Artificial Intelligence/Machine Learning-Enabled Medical Devices: Persistent Specialty Concentration and the Care-Delivery Gap (1995–2025)2026
  3. 3FDA-authorized oncology artificial intelligence and machine learning devices and their clinical evidence: A cross-sectional analysis2026 · 2 citations
  4. 4Role of AI in Clinical Decision-Making: An Analysis of FDA Medical Device Approvals2025 · 1 citations
  5. 5State of Medical AI Adoption: 1,200 Devices Approved, 81% of Hospitals at Zero2026