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AWAK Applied sciences Broadcasts FDA Breakthrough Gadget Designation for his or her Synthetic Intelligence Enabled Kidney Illness Prediction Instrument

AWAK Applied sciences Broadcasts FDA Breakthrough Gadget Designation for his or her Synthetic Intelligence Enabled Kidney Illness Prediction Instrument


SINGAPORE, Nov. 27, 2023 /PRNewswire/ — AWAK Applied sciences (AWAK), a pioneering medical expertise firm growing a wearable dialysis product and different complementary options for power kidney illness (CKD) administration, at present introduced that its kidney illness development prediction (KDPP) Synthetic Intelligence (AI) mannequin for CKD affected person care has been granted Breakthrough Gadget designation by the U.S. Meals and Drug Administration (FDA). The KDPP mannequin helps to evaluate the danger of kidney illness development and initiation of renal substitute remedy (dialysis or transplant), inside a interval of 1 yr, 2 years and 5 years.



Collaboration between AWAK and Ever Fortune.AI (EFAI), a spin-off firm from China Medical College Hospital (CMUH) based mostly in Taiwan, led to the event of this groundbreaking AI resolution. The 2 corporations entered in a strategic partnership in September 2021 to revolutionize the analysis, therapy, and administration of kidney illness by constructing options utilizing medical massive information and synthetic intelligence.


The Breakthrough Gadget designation from the FDA is granted to novel merchandise that display the potential to supply substantial advantages over present medical gadgets or applied sciences. AWAK is immensely pleased with this recognition, which underscores its dedication to advancing affected person care and medical innovation.


Suresha Venkataraya, Chief Government Officer of AWAK Applied sciences, mentioned: “This designation is a key milestone which is able to allow us to speed up product validation and we look ahead to working with the company to assist deliver this predictive AI mannequin into medical apply. We’re delighted to work with our companions on this journey, who share our ardour for bringing transformative options for well timed detection and therapy of kidney illness to cut back the bodily, psychological and monetary burden on the sufferers and the healthcare system.”


Dr. Chin-Chi Kuo of CMUH, Medical Advisor of EFAI, mentioned: “AI is revolutionizing healthcare with machine studying based mostly information intelligence, offering unparalleled insights. The modern AI fashions developed utilizing the CMUH iHi (ignite Hyper-intelligence) platform exemplify this transformation. These fashions provide clinicians superior instruments for CKD administration, enabling efficient danger stratification and optimum useful resource allocation. This innovation heralds a brand new period of proactive, clever kidney care, showcasing a big leap in healthcare expertise and digital affected person administration methods.”


As a way to deal with the unmet wants in managing kidney illness in different areas, AWAK has additionally entered right into a analysis collaboration with Singapore Common Hospital (SGH) to collectively work on growing new AI fashions in addition to testing the prevailing KDPP mannequin utilizing the hospital’s de-identified CKD affected person database.


AWAK can be already in superior discussions with companions in United States for its modern merchandise, to adapt to and combine into the US market. To spearhead this growth, AWAK is relocating Mandar Gori, Chief Enterprise Officer of AWAK, to California, United States, to ascertain a powerful floor presence and speed up partnerships within the area. In the end, the US workforce will increase to construct medical, regulatory, and different capabilities, reinforcing AWAK’s dedication to kidney illness sufferers and their caregivers, globally.


Abel Ang, Chairman of AWAK Applied sciences, mentioned: “We’re thrilled to have acquired a second Breakthrough Gadget Designation from the US FDA, making us one of many few Asia-based MedTech corporations with a number of FDA breakthrough machine designations. With our latest US$20+M collection B fundraise, we’re enthusiastic about increasing our actions into the US, the biggest dialysis market on the planet.”


Media Contacts: 


Priyanka Arya

AWAK Applied sciences Pte Ltd

+65 6950 5011

[email protected]


About AWAK Applied sciences


AWAK Applied sciences Pte. Ltd. is a pioneering, patient-centric medical expertise firm with a mission to reinforce the lives of individuals with kidney illness and their caregivers by offering options to ship higher outcomes and enhance their high quality of life.


Headquartered in Singapore with workplaces in Los Angeles, United States and Bengaluru, India, the corporate is devoted to the analysis, improvement and advertising of novel applied sciences in kidney care. For extra data, please go to: www.awak.com


About Ever Fortune.AI


Ever Fortune.AI Co. Ltd. is a Taiwan-based firm primarily engaged within the analysis, improvement, manufacture and sale of medical and healthcare synthetic intelligence services. The Firm offers medical massive information, AI evaluation, custom-made medical AI options and is dedicated to modern developments in clever drugs and precision drugs as a pioneer of digital healthcare. For extra data, please go to: https://www.everfortuneai.com.tw/en/


About Singapore Common Hospital


Singapore Common Hospital, established in 1821, is the biggest tertiary hospital in Singapore and ranked among the many world’s greatest. It offers probably the most complete patient-centered care with over 50 medical specialties on its campus. As an Tutorial Medical Centre, it takes satisfaction in coaching healthcare professionals and conducting leading edge analysis to satisfy evolving wants of the nation in addition to the area. Pushed by a powerful sense of function, SGH is dedicated to provide of its greatest to heal and produce hope, because it has for over 200 years. For extra data, please go to: www.sgh.com.sg


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SOURCE AWAK Applied sciences Pte Ltd



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