FDA Approves Nephros’ Dual Stage Ultrafilters

RIVER EDGE, N.J.—The U.S. Food and Drug Administration has given Nephros Inc. 501k approval to market its Dual Stage Ultrafilters (DSU) for in-line purification of dialysate water and bicarbonate solution.

"The DSU is Nephros' first FDA approved device in the U.S. and represents an important milestone for the company," said Ernest Elgin, president and CEO of Nephros. "Within dialysis clinics, microbial and endotoxin contamination of the water and dialysate concentrate used to prepare dialysate is an ongoing concern. Nephros' DSU filters are designed to eliminate these contaminants."

The DSU is approved to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.