New Wearable Dialysis Machine Receives FDA Breakthrough Status



Breaking news hit the Chronic Kidney Disease Community as a little known Technology Device Company recently received Breakthrough Device status from the United States Food and Drug Administration (FDA) for its new Wearable Dialysis Machine.

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AWAK Technologies is based out of Singapore, but after it applied for FDA approval, and they saw that the Human Trials conducted at Singapore General Hospital (Singapore's largest acute hospital), were so promising the FDA granted the ultra-portable Dialysis option Breakthrough Device designation.

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A world-first, AWAK's light and wearable Peritoneal Dialysis device disrupts the mode of delivery in which stationary Dialysis is currently offered. The purpose of the featherweight machine is to allow patients to conduct Dialysis on their time (day or night) and while on the go so it is less impactful to their lives. The AWAK Peritoneal Dialysis machine allows Chronic Kidney Disease patients to avoid long hours of connection to traditional Dialysis Machines (see video below):

According to the FDA, Breakthrough Device Designation is granted to expedite the development and review of certain devices that demonstrate potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This device certainly fits the criteria since trial results showed that the wearable Peritoneal Device 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 treatments with the AWAK Dialysis.

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Not eligible for Peritoneal Dialysis? No worries since the AWAK Technologies breakthrough Peritoneal Dialysis research is having impacts and miniturizing Hemodialysis Machines as well. What's more, you will want to continue to follow the Artificial Implantable Kidney and the original Wearable Artificial Kidney which are making steady strides to market release.

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Want to know when and where the next round of Human Trials will be held for the AWAK? Want to learn about the criteria? Complete the below form:

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There is a clear trend to offer light, portable or even implantable Dialysis options. Are you excited for the short and medium term future of Dialysis or do you think that the FDA will refuse to ultimately approve such breakthroughs that could cause radical changes? Share this article far-and-wide so that others know the great progress that is taking place in the Chronic Kidney Disease Community. Also, weigh-in with your own pros and cons at the Facebook Fan Page which has over 86,000 friends (click here). While you are there, like the Facebook Fan Page and visit regularly (300,000 monthly viewers) for the latest tailored breaking news and information which teaches those with Chronic Kidney Disease, Dialysis, Kidney Transplant, Diabetes, and High Blood Pressure how to better manage and improve their lives. You may become a regular visitor like, Charles Griffin who said, "Praise God for KidneyBuzz." 

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