tanzania times : Latest News and In-depth Analysis
Contact Us
Search
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).
[SOMNUM and SOMNUM Medella]
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 theU.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: [email protected]
Address: #517,SPACES,361 Newbury Street,Boston,MA,02115
Website: www.honeynaps.com
In Cameroon, insecurity is triggering a fresh wave of displacement in the Far North. Following an attack attributed to Boko Haram that left 15 people dead, thousands of residents are fleeing towards border towns, raising fears of another humanitarian crisis
Sep 22, 2026
Aid efforts are being hampered by damaged roads, restricted access and a shortage of funding, as fears grow of a wider humanitarian catastrophe.
Sep 17, 2026
Lionel Messi’s international story may not be over just yet. After announcing his retirement from Argentina duty on August 29th, following the World Cup final defeat to Spain and the recent death of his father, Messi is set for one final farewell.
Sep 17, 2026
A joint Nato operation intercepted Russian submarines attempting to destroy a vital undersea cable (Picture: Getty)
Sep 15, 2026