HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
- FDA 510(k) Clearance (K253390) Validates AI-Based Classification of OSA, CSA, and MSA - Subtype-Specific Respiratory Event Analysis Improves Diagnostic Precision and Supports Next-Generation Digital Biomarker Development - Advanced AI Analysis...
HoneyNaps Selected for Korea's 2026 Global ICT Unicorn Program
First SleepTech company selected for Korea's ICT Unicorn Program FDA-cleared AI sleep diagnostic solution strengthens global expansion strategy Simultaneous selection for ICT Unicorn Program and K-VIP boosts U.S. market expansion BOSTON, May 11,...
HoneyNaps' AI Sleep-Diagnosis Software SOMNUM™ Selected as a 2025 Next Generation World Class Product at MOTIR Certification Ceremony
Recognized at the official 2025 World Class Product of Korea Certification Ceremony held at Lotte Hotel World, Seoul Certification affirms SOMNUM's potential to lead the global market within seven years HoneyNaps accelerates global expansion: "We...
HoneyNaps Accelerates Clinical Trial Pipelines with FDA-Cleared AI "SOMNUM"
Enhancing Clinical Efficiency with AI Sleep Analysis: Cutting Both Cost and Time Joint Clinical Studies with CROs: SOMNUM™ AI Sleep Scoring Drives Higher Efficiency FDA-cleared AI solution shortens clinical trial timelines while ensuring data...
HoneyNaps' AI-Powered Sleep Diagnostic Software Designated as 73rd and 74th Innovative Medical Device by South Korea's Ministry of Food and Drug Safety
Simultaneous approval of AI solutions for diagnosing sleep disorders and digital therapeutics for insomnia Domestic certification secured following U.S. FDA approval The only company to possess both AI algorithm development and hardware technology...