- 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 Using Multi-Channel Physiological Signals, with Additional FDA 510(k) Clearances Planned for Future Releases
BOSTON, July 16, 2026 /PRNewswire/ -- HoneyNaps, an AI-based sleep medicine company, today announced that SOMNUM V3.0, its AI diagnosis software for polysomnography (PSG) analysis, has received U.S. Food and Drug Administration (FDA) clearance under clearance number K253390.
SOMNUM is clinical decision support software designed to assist medical professionals in analyzing PSG data, including sleep staging and respiratory event detection. HoneyNaps previously received FDA clearance for SOMNUM V1.1.2, and the latest clearance expands the software's capabilities for automated analysis of sleep-disordered breathing (SDB).
SOMNUM V3.0 automatically detects apnea and hypopnea events and classifies apnea into Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), and Mixed Sleep Apnea (MSA) using AI algorithms. Compared with conventional approaches that primarily assess SDB using composite indices, the software provides event-level classification intended to support more detailed clinical scoring.
According to validation results submitted as part of the FDA clearance process, the algorithms achieved Overall Percent Agreement (OPA) of more than 97% across respiratory event categories, supporting the software's performance in automated event detection and classification.
By analyzing subtle physiological patterns from multi-channel biosignals, SOMNUM V3.0 is designed to distinguish different apnea subtypes that may be challenging to differentiate through manual scoring alone. HoneyNaps believes this capability may support more accurate assessment of sleep-disordered breathing severity and assist clinicians in treatment planning.
The company is also developing next-generation AI technologies and digital biomarkers, including Hypoxic Burden (HB), Arousal Burden (AB), and Ventilatory Burden (VB), to enable more comprehensive evaluation of disease severity and health risks associated with sleep apnea. HoneyNaps plans to pursue additional FDA 510(k) clearances for future SOMNUM versions incorporating these capabilities.
Sean Ha (Tae Kyoung Ha), President of HoneyNaps USA, stated, "The FDA 510(k) clearance for SOMNUM V3.0 represents regulatory validation of our AI algorithm's clinical performance in automatically detecting and differentiating OSA, CSA, and MSA. We remain focused on advancing AI-driven sleep diagnostics through continued innovation in automated analysis and next-generation digital biomarkers."
For further information, please contact:
HoneyNaps USA, Inc.
Christine Kwon / Managing Director
Email: sleep@honeynaps.com
Address: 14th Floor, One Broadway, Cambridge, MA 02142, USA
Website: www.honeynaps.com
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HoneyNaps Receives U.S. FDA 510(k) Clearance for SOMNUM V3.0 for AI-Based Sleep-Disordered Breathing Analysis
Leveraging NTT's core capabilities as a Financial Technology Infrastructure Leader to empower highly regulated FSIs in achieving sovereign private AI.
HONG KONG, July 16, 2026 /PRNewswire/ -- NTT Com Asia, part of the NTT Group, a leading global technology company, has released the service blueprint for its Financial AI Fabric (FAIF) in Hong Kong. Serving as a strategic roadmap to cultivate a resilient, future-ready technology ecosystem for Financial Services Institutions (FSIs), this framework integrates NTT Com Asia (NTT)'s world-class digital infrastructure assets and technologies to support secure, enterprise-grade AI deployment. The blueprint's private AI infrastructure layer unites three key infrastructure components: a photonic highway, AI data centers, and sovereign GPUs, addressing the critical need for Hong Kong FSIs to successfully transition AI workloads out of the sandbox and into full-scale production.
The company chose to debut the blueprint at LEAP East 2026, a premier event that brings together global investment and AI opportunities to Hong Kong.
The Market Challenge: The Shift to Private AI
As AI moves into core financial operations, digital infrastructure has escalated to a primary boardroom priority. Forward-thinking FSIs are shifting from cloud-only approaches to flexible hybrid AI infrastructures that span public cloud, colocation facilities, and sovereign data centers. Market indicators show this infrastructure rebalancing is accelerating rapidly.
This shift is particularly evident in Hong Kong, which has solidified its status as a prominent "Finance-driven AI hub". The city has become the definitive destination for significant overseas investment in recent years, including developments in financial innovations, creating a pressing need for a structured infrastructure roadmap that delivers performance, resilience, and strict regulatory compliance without compromise.
"We are witnessing a fundamental shift in how financial institutions evaluate technology, heavily driven by accelerating regional innovation and a powerful surge in inbound investment from markets like the Middle East into Hong Kong," said Stephen Tsang, Chief Revenue Officer of NTT Com Asia. "As a result, FSI infrastructure investments are no longer just back-end IT considerations—they have become central to boardroom discussions around ROI optimization and risk mitigation. Organizations need infrastructure that serves as predictable business drivers rather than an operational bottleneck."
NTT Financial AI Fabric: Core Infrastructure Reimagined
To meet this shifting enterprise demand, the blueprint's private AI infrastructure layer integrates NTT's core technical capabilities into three interconnected pillars designed to break traditional infrastructure bottlenecks:
- The Photonic Highway: APN InterLink delivers photonic connectivity for high-speed, ultra-low latency data exchange across distributed AI workloads.
- The AI Data Center Foundation: Next-generation data center environments featuring Direct Liquid Cooling (DLC) technology and OCEAN Intelligence™, the AI-driven smart building platform that delivers total operation visibility, predictability and sustainability.
- The Sovereign GPU Layer: A dedicated, secure compute environment designed to support private AI adoption, ensuring FSIs maintain complete data sovereignty and regulatory alignment.
"The infrastructure requirements of financial services are changing rapidly as AI workloads become business-critical," said Steven So, Chief Operating Officer of NTT Com Asia. "To successfully move AI from experimentation and sandbox environments into full-scale production, financial institutions need trusted, high-performance infrastructure. The Financial AI Fabric service blueprint outlines exactly how we aim to build a collaborative, secure ecosystem that empowers enterprises to achieve true sovereign private AI while seamlessly navigating stringent regulatory environments."
Solidifying Hong Kong as the Regional AI Nexus
The recent presentation of the FAIF blueprint at the LEAP East event served as a key platform for industry engagement. Through thought leadership sessions led by NTT executives, regional financial leaders gained first-hand insights into how the blueprint bridges connectivity, AI-ready infrastructure, and sovereign compute capabilities.
"The introduction of the Financial AI Fabric blueprint reflects the company's global capabilities and innovation strength," said Daisuke Kuroda, Chief Executive Officer of NTT Com Asia. "By establishing this service roadmap, we are reinforcing Hong Kong's position as a leading financial AI hub and providing the entire FSI ecosystem with a clear, compliant path toward secure, sovereign private AI."
NTT Hong Kong Digital Infrastructure Portfolio at a Glance
To support the deployment of the Financial AI Fabric blueprint, NTT leverages a robust, live technology foundation across Hong Kong, designed for high-density, mission-critical enterprise workloads:
- Photonic Highway Deployment (APN InterLink): Co-launched by NTT DOCOMO BUSINESS, Inc. and NTT Com Asia, the All-Photonic Network (APN) infrastructure was commercially launched in Hong Kong on November 1, 2025. Leveraging Innovative Optical and Wireless Network (IOWN®) technology, it provides ultra-low latency and energy-efficient connectivity with zero electronic jitter to support high-frequency transactions and intensive distributed AI computing.
- Financial-Grade AI Data Centers: NTT owns and operates two specialized facilities in Hong Kong—the Tseung Kwan O Financial Data Center (FDC) and the Tai Po Data Center (TPDC). Both facilities have been optimized as financial-grade AI data centers, incorporating advanced Direct Liquid Cooling (DLC) systems specifically engineered to handle the thermal and high-density power constraints demanded by complex large language model (LLM) training and inference. Powered by OCEAN Intelligence™, NTT's AI-driven smart operations platform, the data centers leverage AI-driven energy optimization, predictive maintenance, and intelligent operations to enhance efficiency, reliability, and operational resilience.
- Evolving GPU Infrastructure Capabilities: Building upon the photonic backbone and high-density data centers, NTT is actively building its infrastructure footprint to support a GPU-as-a-Service (GPUaaS) launch later this year, giving regional financial institutions access to localized, sovereign compute resources on demand.
About NTT Com Asia
As part of the NTT Group, a leading global technology company, NTT Com Asia is committed to building a smart and sustainable world through innovation. We empower businesses to accelerate their digital and AI journeys by unlocking the full potential of data.
From smart digital infrastructure, technology services to leading-edge AI solutions, we enable organizations to navigate the evolving challenges of a data-centric world.
For more information, please visit: www.ntt.com.hk
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NTT Debuts Financial AI Fabric at LEAP East as Strategic Infrastructure Roadmap to Meet Hong Kong's Financial AI Demands
NTT Debuts Financial AI Fabric at LEAP East as Strategic Infrastructure Roadmap to Meet Hong Kong's Financial AI Demands
