295 New AI Devices Authorized in 2025

In 2025, the FDA authorized 295 new AI/ML-enabled medical devices — the highest single-year authorization count on record and a material acceleration over 2024.

Distribution follows the existing tracker composition: the vast majority in radiology and imaging, continued growth in cardiology (echocardiography AI and coronary CT), and the first meaningful wave of pathology AI tools for whole-slide image analysis reaching clinical deployment.

What the 295 number means:

For clinicians. Vendor density per modality is now high enough that procurement decisions depend on workflow integration and total-cost-of-ownership, not on whether an FDA-authorized tool exists for a given task.

For hospital IT. Integration burden is significant. Each authorized tool brings its own credentialing, security review, integration standard (DICOM, HL7 FHIR), and update cadence. Consolidated AI platforms promising unified management across multiple point-tools are now a credible procurement category.

For innovators. 295 authorizations in a single year means the regulatory bar is established, not exotic. Predicate devices for most imaging use cases exist. Competitive pressure, not regulatory uncertainty, is the dominant market-entry constraint.

The FDA AI/ML device tracker is the authoritative source; it updates on a regular cadence and provides decision memos and clinical-performance summaries for each authorization.