2nd FDA Breakthrough Device Designation!

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2nd FDA Breakthrough Device Designation!

27 November 2023


2nd FDA Breakthrough Device Designation!

SINGAPORE, Nov. 27, 2023 /PRNewswire/ — AWAK Technologies (AWAK), a pioneering medical technology company developing a wearable dialysis product and other complementary solutions for chronic kidney disease (CKD) management, today announced that its kidney disease progression prediction (KDPP) Artificial Intelligence (AI) model for CKD patient care has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). The KDPP model helps to assess the risk of kidney disease progression and initiation of renal replacement therapy (dialysis or transplant), within a period of 1 year, 2 years and 5 years.

Collaboration between AWAK and Ever Fortune.AI (EFAI), a spin-off company from China Medical University Hospital (CMUH) based in Taiwan, led to the development of this groundbreaking AI solution. The two companies entered in a strategic partnership in September 2021 to revolutionize the diagnosis, treatment, and management of kidney disease by building solutions using medical big data and artificial intelligence.

The Breakthrough Device designation from the FDA is granted to novel products that demonstrate the potential to offer substantial benefits over existing medical devices or technologies. AWAK is immensely proud of this recognition, which underscores its commitment to advancing patient care and medical innovation.

Suresha Venkataraya, Chief Executive Officer of AWAK Technologies, said: “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.”

Dr. Chin-Chi Kuo of CMUH, Medical Consultant of EFAI, said: “AI is revolutionizing healthcare with machine learning based data intelligence, providing unparalleled insights. 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.”

In order to address the unmet needs in managing kidney disease in other regions, AWAK has also entered into a research collaboration with Singapore General Hospital (SGH) to jointly work on developing new AI models as well as testing the existing KDPP model using the hospital’s de-identified CKD patient database.

AWAK is also already in advanced discussions with partners in United States for its innovative products, to adapt to and integrate into the US market. To spearhead this expansion, AWAK is relocating Mandar Gori, Chief Business Officer of AWAK, to California, United States, to establish a strong ground presence and accelerate partnerships in the region. In due course, the US team will expand to build clinical, regulatory, and other capabilities, reinforcing AWAK’s commitment to kidney disease patients and their caregivers, globally.

Abel Ang, Chairman of AWAK Technologies, said: “We are thrilled to have received a second Breakthrough Device Designation from the US FDA, making us one of the few Asia-based MedTech companies with multiple FDA breakthrough device designations. With our recent US$20+M series B fundraise, we are excited about expanding our activities into the United States, the largest dialysis market in the world.”

Media Contacts: 

Priyanka Arya
AWAK Technologies Pte Ltd
+65 6950 5011
[email protected]

About AWAK Technologies

AWAK Technologies Pte. Ltd. is a pioneering, patient-centric medical technology company with a mission to enhance the lives of people with kidney disease and their caregivers by providing solutions to deliver better outcomes and improve their quality of life.

Headquartered in Singapore with offices in Los Angeles, United States and Bengaluru, India, the company is dedicated to the research, development and marketing of novel technologies in kidney care. For more information, please visit: www.awak.com

About Ever Fortune.AI

Ever Fortune.AI Co. Ltd. is a Taiwan-based company mainly engaged in the research, development, manufacture and sale of medical and healthcare artificial intelligence products and services. The Company provides medical big data, AI analysis, customized medical AI solutions and is committed to innovative developments in intelligent medicine and precision medicine as a pioneer of digital healthcare. For more information, please visit: https://www.everfortuneai.com.tw/en/

About Singapore General Hospital

Singapore General Hospital, established in 1821, is the largest tertiary hospital in Singapore and ranked among the world’s best. It provides the most comprehensive patient-centered care with over 50 clinical specialties on its campus. As an Academic Medical Centre, it takes pride in training healthcare professionals and conducting cutting edge research to meet evolving needs of the nation as well as the region. Driven by a strong sense of purpose, SGH is committed to give of its best to heal and bring hope, as it has for over 200 years. For more information, please visit: www.sgh.com.sg

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