- 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
BOSTON, Feb. 3, 2025 -- HoneyNaps, a leader in AI-based sleep data analysis, announced on December 16 that its AI-powered sleep disorder diagnostic software, "SOMNUM", and its second-generation digital therapeutic for insomnia, "SOMNUM Medella," have been designated as innovative medical devices by South Korea's Ministry of Food and Drug Safety (MFDS).
What Are Innovative Medical Devices?
Innovative medical devices are advanced technologies integrating high-intensity innovations in fields such as information technology, biotechnology, and robotics. These devices offer significantly enhanced safety and efficacy compared to conventional products. The MFDS designates innovative medical devices in areas like AI medical devices, digital therapeutics, and robotic surgical systems.
Products with this designation enjoy various benefits, such as expedited regulatory review processes and preferential participation in 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 can analyze multi-channel, time-series, and large-scale biometric data in real time. Unlike traditional image-based systems, SOMNUM is built on explainable AI (XAI) technology to enhance transparency and reliability.
- SOMNUM Medella: Designated as the 74th innovative medical device, SOMNUM Medella leverages HoneyNaps' proprietary contactless sleep data monitoring system, "SOMNUM Scanning." This system combines objective sleep analysis data with AI to create personalized treatment modules for insomnia, maximizing patient compliance and treatment outcomes.
HoneyNaps' Unique Position
The MFDS has designated 74 innovative medical devices to date, with only seven companies receiving multiple designations. HoneyNaps stands out as the sole company with capabilities in both AI algorithm development and hardware technology.
Decades of Innovation Recognized
A representative from HoneyNaps commented, "For over a decade, we have focused on developing solutions spanning the entire spectrum of sleep data sensing, analysis, diagnosis, and treatment. We are thrilled that our technological innovations and efforts have been officially recognized through this designation."
Building on the U.S. FDA approval secured in 2023, the company aims to enhance its sleep data platform to better suit domestic medical needs, supporting healthcare professionals in delivering accurate diagnoses and effective treatments for sleep disorders.
For further information, please contact:
HoneyNaps USA, Inc.
Christine Kwon / Managing Director
Email: sleep@honeynaps.com
Address: #517, SPACES, 361 Newbury Street, Boston, MA, 02115
Website: www.honeynaps.com
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