HoneyNaps Secures Groundbreaking Medical Device Designations in Korea for AI Sleep Solutions

HoneyNaps' AI Sleep Solutions Receive Medical Device Designations

HoneyNaps, a prominent name in AI-driven sleep data analytics, announced groundbreaking developments on December 16, 2023. Their innovative sleep disorder diagnostic software, SOMNUM, alongside the second-generation therapeutic for insomnia, SOMNUM Medella, were designated as innovative medical devices by South Korea's Ministry of Food and Drug Safety (MFDS). This dual recognition marks HoneyNaps as a leader in the intersection of technology and healthcare.

Details of the Medical Device Designations

The MFDS aims to drive the safety and efficiency of medical innovations by recognizing devices that integrate revolutionary features in information technology, biotechnology, and robotics. Under this designation, SOMNUM achieved recognition as the 73rd innovative medical device, while SOMNUM Medella received the designation as the 74th. These distinctions allow HoneyNaps to benefit from accelerated regulatory processes and enhanced access to government-supported initiatives.

SOMNUM functions as a deep learning-based AI interpretation system, adept at analyzing large-scale biometric data streams in real-time. Unlike traditional systems reliant on imagery, SOMNUM is grounded in explainable AI (XAI) technology, providing transparency and enhancing reliability.

Meanwhile, SOMNUM Medella combines HoneyNaps' proprietary contactless sleep data monitoring with advanced AI, optimizing treatment options for insomnia and improving compliance and outcomes for patients.

The Unique Offering of HoneyNaps

To date, the MFDS has recognized only 74 innovative medical devices, with a mere seven companies receiving multiple designations. HoneyNaps distinguishes itself as the only entity capable of both AI algorithm creation and hardware integration, positioning it uniquely within the healthcare market.

A Decade of Innovation Recognized

A representative from HoneyNaps expressed pride in their decade-long commitment to developing solutions across the entire sleep data spectrum—from sensing to analysis, diagnosis, and treatment. They highlighted that this recognition underscores their technological advancements and dedication to improving sleep health.

Following the U.S. FDA approval acquired in 2023, HoneyNaps plans to refine its sleep data platform further, focusing on meeting domestic medical requirements. The company's efforts will bolster healthcare professionals' capabilities to diagnose and treat sleep disorders accurately and efficiently.

For more detailed inquiries, please contact HoneyNaps USA, Inc. Christine Kwon, Managing Director, via email at [email protected] Visit their website for more information at www.honeynaps.com.