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HoneyNaps, AI Sleep Diagnosis Software ‘SOMNUM V3.0’ FDA Receives FDA Approval

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입력 2026.07.21 09:40

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OSA·CSA·MSA distinguish algorithm’s clinical accuracy validated through FDA new approval
AI automatic decipher advancement and next generation digital biomarker development get under way

[Young journalist Yeon Cheon] AI sleep healthcare specialized company, HoneyNaps unveiled that they got FDA approval for ‘SOMNUM V3.0’, AI based sleep diagnosis software.

FDA approval code for this is K253390.

SOMNUM is a healthcare AI system that features sleep stages and sleep related primary event analyzation based on Polysomnography. HoneyNaps already got FDA approval for SOMNUM V1.1.2, and from this time’s V3.0 approval, they were able to advance product and strengthen U.S. market expansion base.

SOMNUM V3.0 is built to automatically diagnose apnea and hypopnea, and distinguish and analyze apnea into obstructive sleep apnea, central sleep apnea, and mixed sleep through AI algorithm.

The company explained that they increased event analysis performance by gaining Overall Agreement of 97~99% in each respiratory event. This can be used in increasing decipher accuracy that is needed in sleep-disordered breathing severity evaluation and treatment direction determination.

Alongside with SOMNUM V3.0 commercialization, HoneyNaps is also working on automatic AI evaluation technology and next generation digital biomarker development. By using Hypoxic Burden, Arousal Burden, and Ventilatory Burden, they are working on a technology that evaluates sleep apnea patient’s symptom severity and health risk in detail, and they are planning to prepare additional FDA approval for the next version that includes such features.

HoneyNaps company official had said “This FDA approval means that SOMNUM V3.0’s respiratory event distinguish algorithm got verified for its clinical accuracy in American regulation standard, and “the company will strengthen competitiveness in global sleep diagnosis AI market by the development of follow-up version that applied digital biomarker.”

▶원문 기사: 허니냅스, AI 수면진단 소프트웨어 ‘SOMNUM V3.0’ FDA 승인 (이코노미스트, 2026. 7. 3)

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