Projects

Neudive Co., Ltd., a company specializing in the development of digital medical devices for individuals with developmental disabilities, was selected on April 16, 2025 as the priority negotiation candidate for the 'Development of Digital Medical Devices for ASD Treatment' project administered by the National Mental Health Center. Accordingly, following the signing of an agreement with the National Mental Health Center within April 2025, Neudive will receive up to 5 billion KR

Neudive Co., Ltd., a company specializing in the development of digital medical devices for individuals with developmental disabilities, signed an MOU with the Hanshin University SW-Centered University Program on March 25, 2025. The Hanshin University SW-Centered University Program specializes in nurturing convergence talent to lead the AI-SW-based digital lifecare service industry for people with disabilities and seniors, with a focus on providing digital inclusion to digita

Neudive was selected for the 2024 Data Voucher Program, administered by the National IT Industry Promotion Agency (NIPA) under the Ministry of Science and ICT. In collaboration with partner company Insighter, Neudive plans to carry out a project on 'Voice Signal Analysis for Children with Autism.' Insighter has experience in building child voice datasets and developing child voice-specialized speech recognition models through a 2022 AI training data construction project.

Neudive received approval from the Ministry of Food and Drug Safety (MFDS) on May 24, 2024 for the confirmatory clinical trial plan for its social skills digital therapeutic NDTx-01 (Buddy-in). This is a multi-institutional, randomized, evaluator-blinded, superiority confirmatory clinical trial designed to evaluate the safety and efficacy of the cognitive therapy software 'NDTx-01' for improving social situational awareness and interaction in children and adolescents with Aut

Neudive obtained the Certificate of Good Manufacturing Practice (GMP) for Medical Device Manufacturing and Quality Management Standards on February 2, 2024. Based on NDTx-01, Neudive's social skills improvement digital therapeutic for children and adolescents with Autism Spectrum Disorder and Social Communication Disorder, an on-site audit was conducted over three days from December 19 to 21, 2023, covering internal procedures related to medical device manufacturing, includin

Neudive's digital therapeutic device for promoting social skills in individuals with Autism Spectrum Disorder and Social Communication Disorder, NDTx-01, was issued a 'Medical Device Test and Inspection Report' by the Korea Testing Laboratory (KTL) on December 16, 2023. The performance test report includes a 'Software Verification and Validation Report (IEC 62304)' and a 'Cybersecurity Requirements Verification Report (Ministry of Food and Drug Safety Medical Device Cybersecu

The Ministry of Health and Welfare announced on the 21st that it will support 31 projects selected for the 'Hospital-Based Digital Healthcare Validation and Adoption (R&D)' initiative through 2025, with the aim of accumulating empirical data needed for evidence-based digital healthcare utilization. Through this initiative, the Ministry plans to support multi-institutional clinical validation so that digital healthcare products with high technological maturity can be utilized