Awak Technologies said today that it won a breakthrough device designation from the FDA for its wearable Awak Peritoneal Dialysis system. The Awak PD system is a portable, wearable peritoneal dialysis system which allows dialysis to be performed “on-the-go”, the Singapore-based company said. The breakthrough designation was granted based on results from the first-in-human safety […]
MASSDEVICE ON CALL — Singapore’s Awak Technologies Pte. has cut a dialysis machine down to the size of a purse with its portable, wearable artificial kidney.
The product is undergoing animal and lab tests in Singapore and the company hopes to submit data for European and U.S. regulatory review in 2013.
Several U.S. companies are simultaneously developing their own wearable hemodialysis machines, but none have yet hit the market, the Wall Street Journal reported.