– Medical device quality and safety verified by the Ministry of Food and Drug Safety, International Electrotechnical Commission, etc.
– Accelerating clinical trials and global expansion… Research also underway to commercialize brainwave-based solutions
Slowave Inc. (CEO Ryu Kyung-ho), a digital healthcare startup based on brainwave analysis, announced that it has simultaneously obtained 'Good Manufacturing Practice (GMP)' certification for its brainwave analysis medical device and international certification related to product safety.
Slowwave is currently developing medical devices that support medical professionals' precise diagnosis using an ultra-small electroencephalograph and an electroencephalogram analysis algorithm, including ▲ an electroencephalogram measurement solution for insomnia patients, ▲ a solution for predicting delirium after surgery, and ▲ an aid for early screening of mental illness.
Slowwave's GMP certification is a judgment of suitability for medical device manufacturing and quality control from the Ministry of Food and Drug Safety, which enables Slowwave to not only prove the manufacturing quality level required in the medical field, but also conduct medical device clinical trials. In addition, Slowwave also obtained the 'CB certification', which verifies the safety of electrical and electronic products according to the technical standards of the International Electrotechnical Commission (IEC), thereby securing the technology and safety requirements for entering the global medical device market.
Based on this, Slowwave plans to conduct research to commercialize various brainwave-based solutions, including ▲Attention Deficit Hyperactivity Disorder (ADHD) screening ▲Digital Therapeutics (DTx) ▲Delirium Prediction in ICUs.
Slowwave CEO Ryu Kyung-ho said, “This achievement shows that in addition to Slowwave’s excellent brainwave technology, the quality and stability of our medical devices have reached a global level,” and added, “We will focus on accumulating clinical data and advancing technology to increase reliability and further secure global competitiveness.”
Meanwhile, Slowwave has been recognized for its technological prowess and business viability, including passing the Deep Tech Tips project through the fast track after receiving initial investment from SparkLabs, being selected as the best company in the 2023 Ministry of SMEs and Startups' Early Startup Package, and being selected as a company supported by the 2024 Startup Leap Package.
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