Another Device Gets Added to the Peritoneal Dialysis Mix

AWAK Technologies has been granted a breakthrough device designation from FDA for a wearable and ultra-portable peritoneal dialysis (PD) device. The Singapore-based company’s AWAK PD device allows dialysis to be performed "on-the-go", overcoming the challenge of long hours of therapy and connection to large-size dialysis machines, currently faced by renal patients. The company said FDA’s designation was granted after reviewing the results from the First-In-Human safety trial of AWAK PD device, which was successfully completed in October 2018 at the Singapore General Hospital, Singapore's largest acute tertiary hospital. The trial results showed that AWAK PD was able to efficiently remove the accumulation of toxins from the body and patients in the trial did not experience any serious adverse events during dialysis with AWAK PD. “Breakthrough Device Designation is an important milestone in the development of AWAK PD following the recent positive clinical study results,” Suresha Venkataraya, CEO of AWAK, said in a release. “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." Are you ready for MD&M West? Join us from Feb. 5 - Feb. 7 for medtech's premiere event in Anaheim, CA.Â&...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news