SOMNUM V3.0 Software Cleared by FDA for Automated Sleep-Disordered Breathing Analysis
KEY TAKEAWAYS
- The FDA granted 510(k) clearance for SOMNUM V3.0, HoneyNaps’ AI-based software for polysomnography analysis.
- The software detects apnea and hypopnea events and classifies apnea events as obstructive, central, or mixed.
- HoneyNaps reported overall percent agreement greater than 97% across respiratory event categories in validation data submitted to the FDA.
The FDA granted 510(k) clearance for SOMNUM V3.0 (HoneyNaps, Boston, MA), a software platform based on artificial intelligence (AI) designed to assist clinicians with polysomnography analysis. In 2023, HoneyNaps’ initial SOMNUM software received 510(k) clearance for the real-time analysis of polysomnography records. HoneyNaps stated in a press release that the new clearance expands the software’s automated sleep-disordered breathing analysis capabilities.
SOMNUM is clinical decision support software intended to support sleep staging and respiratory event detection using polysomnography data. The V3.0 update adds automated detection of apnea and hypopnea events and classifies apnea events into obstructive sleep apnea, central sleep apnea, and mixed sleep apnea categories.
Clearance Highlights
- According to HoneyNaps, SOMNUM V3.0 uses AI algorithms to analyze multichannel physiologic signals from polysomnography studies.
- The software provides event-level respiratory classification rather than relying only on composite sleep-disordered breathing indices.
- HoneyNaps reported overall percent agreement of more than 97% across respiratory event categories in validation results submitted for FDA review.
- The company is developing additional AI-based measures, including hypoxic burden, arousal burden, and ventilatory burden, for potential inclusion in future versions.
HoneyNaps stated that it plans to seek additional FDA 510(k) clearances for future SOMNUM releases incorporating next-generation digital biomarker capabilities. SOMNUM V3.0 is intended to support clinician interpretation of polysomnography data and does not replace clinical judgment.
Source
HoneyNaps. HoneyNaps receives U.S. FDA 510(k) clearance for SOMNUM V3.0 for AI-based sleep-disordered breathing analysis. PR Newswire. Published July 16, 2026. Accessed August 5, 2026. https://www.prnewswire.com/news-releases/honeynaps-receives-us-fda-510k-clearance-for-somnum-v3-0-for-ai-based-sleep-disordered-breathing-analysis-302827031.html