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FDA Clears HoneyNaps Ai Software for Sleep Apnea Analysis

Published

16 July 2026

Topic

opportunities

Sectors

Digital Health

Geography

United States

Source

Read at respiratory-therapy.com

Verified

Fusion42 · 16 July 2026 · Fusion42 review

FDA cleared HoneyNaps' Somnum V3.0 AI software for automated detection and classification of obstructive, central, and mixed sleep apnea with 97% accuracy. The tool assists healthcare professionals in polysomnography analysis and the company plans to add hypoxic, arousal, and ventilatory burden markers in future versions.

This Wire brief sits within Fusion42's coverage of Digital Health.

◆ The Wire takeaway

If you build sleep diagnostic hardware or sell into sleep labs, your workflow just became a target for displacement. HoneyNaps has proven FDA will clear AI that replaces manual scoring — the next vendor to hit this market will hunt for your installed base.

Coverage

1 source · 16 Jul 2026

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Topics

Digital Healthfda-510k-clearancesleep-apnea-aidiagnostic-automationclinical-decision-supportpolysomnography