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Nephros Receives FDA 510(k) Clearance for HDF Assist Module
The First and Only FDA-Cleared Device Available in the United States to Provide Hemodiafiltration Therapy to Dialysis Patients SOUTH ORANGE, NJ, May 17, 2022
About this update from Nephros, Inc.
[{"type":"text","content":"The First and Only FDA-Cleared Device Available in the United States to Provide Hemodiafiltration Therapy to Dialysis Patients SOUTH ORANGE, NJ, May 17, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Nephros, Inc. (Nasdaq: NEPH), a leading water technology company providing filtration and pathogen detection solutions to the medical and commercial markets, today announced that it has received FDA 510(k) clearance for its patented, second-generation HDF Assist Module. The HDF Assist Module is the first and only device in the United States cleared to provide hemodiafiltration (HDF) therapy to patients with End-Stage Renal Disease (ESRD). “Receiving 510(k) clearance is truly a milestone moment for Nephros and Specialty Renal Products (SRP), our majority-owned subsidiary. Nephros was founded with the goal of providing solutions for patients with ESRD, and today is a big step forward in the process,” said Andy Astor, President and Chief Executive Officer of both Nephros and SRP. “The receipt of FDA clearance for our HDF Assist Module enables us to provide ESRD patients with a new therapeutic option.” “Our HDF Assist Module is an innovation that offers practitioners the opportunity to use an existing hemodialysis (HD) machine to provide HDF therapy without the purchase of a new, costly machine,” continued Mr. Astor. “SRP’s Director of Commercial Operations, David Lee, an engineer and dialysis nurse with many years of clinical operations responsibility, will lead our initial focus on piloting the HDF Assist Module within select dialysis clinics.” “Our first goal in any given dialysis clinic will be to support the development of internal procedures for operation of the HDF Assist Module, and the training of personnel to seamlessly execute those procedures,” said Mr. Lee. “Once the procedures are established and tested within the select clinics, we will then be able to work with additional clinics to roll out HDF as a therapeutic option for more dialysis patients.” About Nephros Nephros, Inc. is a company committed to improving the human relationship with water through leading, accessible technology. We provide innovative filtration and pathogen detection as part of an integrated approach to water safety that combines science, solutions, and support services. Nephros products serve the needs of customers within the healthcare and commercial ...