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FDA grants breakthrough designation to wearable dialysis device

from MedTech Dive

FDA has granted breakthrough device designation to a wearable, portable peritoneal dialysis device made by Singapore-based AWAK Technologies. FDA authorized the designation for patients with end-stage renal disease based on results from a first-in-human safety trial of the AWAK Peritoneal Dialysis device completed in October 2018 at Singapore General Hospital. more

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