HoneyNaps, a leader in AI-driven sleep data analysis, proudly announces that its AI-powered sleep disorder diagnostic software, “SOMNUM”, and its second-generation digital therapeutic for insomnia, “SOMNUM Medella”, have both been designated as innovative medical devices by South Korea’s Ministry of Food and Drug Safety (MFDS) on December 16.
What Are Innovative Medical Devices?
Innovative medical devices are state-of-the-art technologies incorporating cutting-edge advancements in areas such as information technology, biotechnology, and robotics. These devices offer significantly improved safety and efficacy when compared to conventional products. The MFDS designates devices as innovative in sectors like AI medical devices, digital therapeutics, and robotic surgical systems.
With this designation, products benefit from advantages such as accelerated regulatory reviews and preferential access to government-supported programs.
Details of SOMNUM and SOMNUM Medella:
- SOMNUM:
- Designated as the 73rd innovative medical device, SOMNUM is a deep learning-based AI interpretation system that processes multi-channel, time-series, and large-scale biometric data in real time.
- Unlike traditional image-based diagnostic systems, SOMNUM leverages explainable AI (XAI) technology, offering enhanced transparency and reliability for more accurate sleep disorder diagnoses.
- SOMNUM Medella:
- Designated as the 74th innovative medical device, SOMNUM Medella integrates HoneyNaps’ proprietary contactless sleep data monitoring system, SOMNUM Scanning.
- By combining objective sleep analysis with AI, SOMNUM Medella creates personalized treatment modules for insomnia, ensuring improved patient compliance and enhanced treatment outcomes.
HoneyNaps’ Unique Position:
HoneyNaps stands out as one of the seven companies in South Korea to receive multiple designations for innovative medical devices. It is the only company with expertise in both AI algorithm development and hardware technology for sleep data analysis and treatment.
Decades of Innovation Recognized:
A representative from HoneyNaps shared, “For over a decade, we have been developing solutions that span the entire spectrum of sleep data sensing, analysis, diagnosis, and treatment. We are proud that our technological advancements and efforts have been officially recognized through this designation.”
Building on its U.S. FDA approval secured in 2023, HoneyNaps plans to further enhance its sleep data platform to meet domestic medical needs, supporting healthcare professionals in delivering more precise diagnoses and effective treatments for sleep disorders.
