AWAK Technologies Earns FDA Breakthrough Status for AI-Driven Kidney Disease Predictor


AWAK Technologies, a forefront medical technology company specializing in wearable dialysis products and solutions for chronic kidney disease (CKD) management, announced the FDA Breakthrough Device designation for its kidney disease progression prediction (KDPP) Artificial Intelligence (AI) model. The collaboration with Ever Fortune.AI (EFAI), a spin-off from China Medical University Hospital (CMUH) in Taiwan, led to the development of this innovative AI solution.

The Breakthrough Device designation from the FDA is a recognition of the potential benefits this AI model brings to CKD patient care. It signifies a significant step in AWAK’s commitment to advancing patient care and medical innovation, expediting the product validation process.

The CMUH iHi (ignite Hyper-intelligence) platform played a crucial role in developing advanced AI models that provide clinicians with sophisticated tools for CKD management, facilitating effective risk stratification and optimized resource allocation. This development represents a notable advancement in proactive, intelligent kidney care and healthcare technology.

To address global needs in kidney disease management, AWAK has collaborated with Singapore General Hospital (SGH). Together, they aim to develop new AI models and assess the existing KDPP model using SGH’s de-identified CKD patient database, extending the impact of this innovative approach.