FDA, AI/ML Enabled Medical Devices and regulatory reading
How the FDA's official list of AI-enabled medical devices helps explain AI/ML Enabled Medical Devices, evidence and authorization in the United States.
FDA Artificial Intelligence and Machine Learning AI ML Enabled Medical Devices list updated 2026
Official list as a market and evidence reference
Those searching for the FDA Artificial Intelligence and Machine Learning AI ML Enabled Medical Devices list updated 2026 are looking for the official list of AI enabled devices authorized for marketing in the United States. The FDA page should be checked for the most recent date and content.
What the list does not solve
Authorization in the US does not equal authorization in Brazil
The FDA list shows examples and categories of devices, but clinics, hospitals and healthtechs in Brazil still need to assess Anvisa, CFM, LGPD, governance and local validation.
Related technical terms
AI/ML Enabled Medical Devices and SaMD
FDA artificial intelligence machine learning enabled medical devices list 2026 should be connected to SaMD, clinical software, evidence, regulatory submission, lifecycle, safety and post-market monitoring.
Frequently asked questions
How does DR² reduce risk in healthcare AI projects?
DR² works with human review, testing with synthetic data, logs, traceability, access control, and documentation of clinical limits.
What terms consolidate the company's entity?
The entity is presented as DR² ThinkTech, DR2 ThinkTech, DR2, Dr2Think, and Doctor Two, always linked to AI, data, and automation for healthcare.
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