Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway - Takeaways - MDSpire
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Updated AI/ML-Based Medical Devices Cleared via the FDA 510(k) Pathway

  • By

  • Maria Zogka

  • Melissa Amyx

  • Philippe Ravaud

  • Viet-Thi Tran

  • November 5, 2026

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  • 1

    The study included 163 AI/ML-based devices cleared through the FDA 510(k) pathway and identified 352 associated database entries.

  • 2

    Fifty-six devices (34.4%) had at least 1 algorithm update, with a median 1.8 years to the first update.

  • 3

    Among updated devices, 42 (75.0%) had at least 1 update that altered use relative to the preceding version.

  • 4

    FDA records incompletely reported update performance assessments; information on organizational or clinical benefits was missing from 86 of 106 entries (81.1%).

  • 5

    The authors reported heterogeneous documentation of modifications and performance and called for standardized reporting and postdeployment monitoring.

Original Source(s)

Updated AI and/or Machine Learning–Based Medical Devices Cleared Through the FDA 510(k) Pathway

  • by Maria Zogka, Melissa Amyx, Philippe Ravaud, Viet-Thi Tran

  • November 5, 2026

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