Neurology
SOMNUM
Honeynaps Co., Ltd.
FDA
FDA-cleared AI medical device
AI-enabled software intended as an aid in the diagnosis of sleep and respiratory-related sleep disorders. It analyses digital polysomnography data from adult patients, with automatic scoring of sleep stages, arousals, respiratory events and leg-movement events, plus manual scoring and re-scoring, display, summarisation and report generation, under the supervision of a physician.
FDA Submission Metadata
- Submission number
- K253390
- Decision date
- June 2026
- FDA panel
- Neurology
- Product code
- OLZ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA