Silvia Health, an agetech startup developing an AI-based non-face-to-face cognitive healthcare platform, announced that its digital-based cognitive healthcare software, 'SILVIA Rx', which is under development, has received GS (Good Software) certification level 1.
GS certification is a nationally recognized system that verifies the quality of domestic software. Specialized organizations, including the Telecommunications Technology Association (TTA), evaluate nine core criteria, including functionality, reliability, usability, and efficiency, based on international standards such as ISO/IEC 25023, 25041, and 25051. SILVIA Rx passed the evaluation, demonstrating its technical perfection and stability.
SILVIA Rx is a digital-based software currently under development to support cognitive health management in adults at risk for mild cognitive impairment. Clinical trials are currently underway to confirm its safety and suitability for use. Silvia Health previously obtained a certificate of conformity to the Korea Good Manufacturing Practices (K-GMP) for medical devices, and SILVIA Rx has been designated as an innovative medical device by the Ministry of Food and Drug Safety. The company plans to complete confirmatory clinical trials and obtain medical device product approval by 2026, aiming for commercialization.
Building on this GS certification, Silvia Health plans to strengthen the connection between its AI-based, non-face-to-face cognitive health management platform, "SILVIA Wellness," and SILVIA Rx, to build an integrated digital solution encompassing everything from cognitive decline risk assessment to management. Through this, the company aims to increase accessibility and sustainability of cognitive health management.
Silvia Health is continuously advancing cognitive health management solutions based on its software development capabilities and quality management system in the digital healthcare field.
- See more related articles
You must be logged in to post a comment.