First Wearable Artificial Kidney on Fast Track to Win FDA Approval
From: Medical Design Technology - 11/03/2015

The Food and Drug Administration (FDA) has awarded its new Expedited Access
Pathway (EAP) to the first Wearable Artificial Kidney (WAK) invented by UCLA
/ Cedars Sinai Nephrologist Dr. Victor Gura of Beverly Hills, CA. The EAP
designation signals FDA support for expediting the availability of this
device to the 600,000 patients suffering from End-Stage Renal Disease (ESRD)
in the United States alone. This development also offers new hope for the
millions of hemodialysis patients around the globe.

The first U. human trials of the externally worn WAK have been conducted at
the University of Washington at Seattle - the details of which will be
presented at the American Society of Nephrology's annual conference ASN
Kidney Week in San Diego, CA on 11/07/2015. Successful human trials have also
been conducted in the UK and Italy. The WAK represents the first material
advancement in dialysis technology in several decades. The mortality rate for
ESRD patients in the US is 20% and rising.

Read the entire article at:
http://www.mdtmag.com/news/2015/11/first-wearable-artificial-kidney-fast-track-win-fda-approval

Links:
Wearable Artificial Kidney (WAK)
http://drgura.com/wearable-artificial-kidney

Victor Gura
http://drgura.com