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 trial of the Awak PD device, which completed last October.
Data from the trial indicates that the system was able to efficiently remove the accumulation of toxins from the body with no serious adverse events experienced by patients using the device, the company said.
“Breakthrough Device Designation is an important milestone in the development of Awak PD following the recent positive clinical study results. The designation reinforces our belief that Awak PD has the potential to revolutionize the way in which peritoneal dialysis can be delivered and we look forward to collaborating closely with the FDA on the next stages of our development pathway,” CEO Suresha Venkataraya said in a prepared statement.
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