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FDA issues breakthrough device designation for CKD monitoring tool

FDA issues breakthrough device designation for CKD monitoring tool
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AWAK Technologies Announces FDA Breakthrough Device Designation for their Artificial Intelligence Enabled Kidney Disease Prediction Tool

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

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