AWAK Nets Breakthrough Status for AI-Powered Kidney Disease Prediction

AWAK Technologies has been granted breakthrough status from the U.S. Food and Drug Administration (FDA) for its kidney disease progression prediction (KDPP) artificial intelligence (AI) model for chronic kidney disease (CKD) patient care.
 
The KDPP model, according to AWAK, helps evaluate the risk of kidney disease progression and initiation of renal replacement therapy within one, two, and five years.
 
AWAK collaborated with Ever Fortune.AI (EFAI), a China Medical University Hospital (CMUH) spinoff based in Taiwan, to develop the AI solution. The duo began a strategic partnership in 2021 aiming to revolutionize diagnosis, treatment, and management of kidney disease by building tools using medical big data and AI.
 
Suresha Venkataraya, CEO of AWAK, told the press, “This designation is a key milestone which will enable us to accelerate product validation and we look forward to working with the agency to help bring this predictive AI model into clinical practice. We are delighted to work with our partners in this journey, who share our passion for bringing transformative solutions for timely detection and treatment of kidney disease to reduce the physical, mental and financial burden on the patients and the healthcare system.”
 
“AI is revolutionizing healthcare with machine learning based data intelligence, providing unparalleled insights,” added CMUH’s Dr. Chin-Chi Kuo, who is also a medical consultant of EFAI. “The innovative AI models developed using the CMUH iHi (ignite Hyper-intelligence) platform exemplify this transformation. These models offer clinicians advanced tools for CKD management, enabling effective risk stratification and optimal resource allocation. This innovation heralds a new era of proactive, intelligent kidney care, showcasing a significant leap in healthcare technology and digital patient management strategies.”
 
AWAK also entered a research collaboration with Singapore General Hospital to jointly develop new AI models and test the KDPP model using the hospital’s de-identified CKD patient database. The company recently raised $20 million in funding for its upcoming U.S. pivotal trial for its wearable dialysis device.