Summary:
South Korea’s Ministry of Food and Drug Safety (MFDS) has designated HoneyNaps’ AI-powered sleep disorder diagnostic software, SOMNUM, and its second-generation digital therapeutic for insomnia, SOMNUM Medella, as innovative medical devices. This designation recognizes their advanced safety and efficacy compared to conventional products and grants benefits such as expedited regulatory review. HoneyNaps is the only company listed with expertise in both AI algorithm development and hardware technology. The company aims to build on this recognition to further enhance its sleep data platform for improved diagnosis and treatment of sleep disorders.
Key Takeaways:
- AI Sleep Solutions Recognized as Innovative – HoneyNaps’ SOMNUM and SOMNUM Medella have been designated as innovative medical devices by South Korea’s MFDS, highlighting their advanced AI-driven capabilities.
- Regulatory and Market Benefits – The designation grants these products access to faster regulatory reviews and government-supported programs, potentially accelerating their adoption in clinical settings.
- Expanding Global Reach – With previous FDA approval in 2023, HoneyNaps aims to refine its sleep data platform to better meet domestic medical needs and improve patient outcomes.
HoneyNaps announced that its artificial intelligence (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).
Innovative medical devices are advanced technologies integrating high-intensity innovations in fields such as information technology, biotechnology, and robotics. The designation signifies the devices offer 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 receive various benefits, such as expedited regulatory review processes and preferential participation in government-supported programs.
SOMNUM and SOMNUM Medella as Innovative Medical Devices
The MFDS has designated 74 innovative medical devices to date, with seven companies receiving multiple designations. HoneyNaps is currently the only company listed with capabilities in both AI algorithm development and hardware technology.
Details of SOMNUM and SOMNUM Medalla are as follows:
- 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 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.
“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,” a representative from HoneyNaps comments in a release.
Building on the US Food and Drug Administration 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.
Photo caption: SOMNUM and SOMNUM Medella
Photo credit: HoneyNaps
