Navigation Links
Nephros Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration System
Date:7/7/2010

RIVER EDGE, N.J., July 7 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that the U.S. Food and Drug Administration has issued a formal response to the company's 510(k) application.

On June 30, Nephros received a final decision letter from the FDA for the company's 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for the company's hemodiafiltration (HDF) system.

"We are disappointed both by the FDA's decision to reject our application and by the fact that the company was not provided an opportunity to address the current comments prior to a final decision being rendered," said Paul A. Mieyal, acting CEO of Nephros.  "After more than 15 months without a substantive communication, the company expected either an approval or further dialogue as the next step in the process.  We feel that the issues raised in the current letter are addressable and have requested an in-person meeting with the review team to discuss options for moving forward."

"Outside of the United States, hemodiafiltration is widely regarded by nephrologists as the gold standard therapy for dialysis patients.  We are disappointed that the availability of HDF therapy in the U.S. has been further delayed," commented Lawrence J. Centella, a member of Nephros's Board of Directors and former Chief Operating Officer of Gambro Healthcare, Inc.

Next Steps

Nephros has requested an in-person meeting to discus
'/>"/>

SOURCE Nephros, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Nephros and AmeriWater Announce Dual Stage Ultrafilters to be a Standard Component of MRO Series Water Treatment Systems
2. Nephros Reports 2010 First Quarter Financial Results
3. Nephros Signs Development Agreement with STERIS
4. Nephros Signs Canadian Distribution Agreement with Bellco Health Care Inc.
5. Nephros Reports 2009 Third Quarter Financial Results
6. Nephros Completes Pivotal U.S. Clinical Trial for its Hemodiafiltration Products
7. Watsons Generic Prograf® 5 mg Receives FDA Approval
8. Renhuang Pharmaceuticals Receives Approval to List on the NYSE Amex
9. Sangamo BioSciences Receives Michael J. Fox Foundation Funding to Develop Novel Drug for the Treatment of Parkinsons Disease
10. Biomerix Ventral Hernia Repair Mesh Receives FDA 510(k) Clearance
11. AMS Receives 510(k) Clearance of Its Revolutionary MoXy(TM) Liquid Cooled Fiber for Fast, Safe Treatment of Enlarged Prostate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/21/2014)... SUNNYVALE, Calif. , Nov. 20, 2014 /PRNewswire/ ... Study at the 2014 AAGL Global Congress demonstrates ... vaginal insert designed to provide bowel control. One of ... MD, Associate Professor and Division Chief of Urogynecology ... North Carolina, won an Award for Best Written ...
(Date:11/21/2014)... , Nov. 20, 2014   Wellcentive , ... (PHM) for healthcare organizations, announced today being named ... 2014 Intel Innovation Award .  Sponsored by Intel, ... in its fourth year, recognizes companies developing leading-edge ... healthcare delivery processes. Wellcentive,s ...
(Date:11/18/2014)... 18, 2014  Sanguine Biosciences – a biotechnology ... study recruitment – will use its proprietary mobile ... Pfizer Inc. find and recruit people diagnosed with ... members to participate in voluntary research, which will ... and hopefully aid in informing the development of ...
Breaking Medicine Technology:LIFE Study Prominently Featured at Minimally Invasive Gynecology Conference 2LIFE Study Prominently Featured at Minimally Invasive Gynecology Conference 3Wellcentive Named Finalist for 2014 Intel Innovation Award 2Wellcentive Named Finalist for 2014 Intel Innovation Award 3Sanguine's Mobile Application to Assist Recruitment for Pfizer Inc. Chronic Pain Research 2
(Date:11/21/2014)... November 21, 2014 For many busy people, ... office visits and months of recovery from dental surgery that ... even at the cost of their youthful appearance. , But ... Art Institute in Oxnard and Woodland Hills, Calif., can provide ... visit, even in instances where the patient’s bone has deteriorated. ...
(Date:11/21/2014)... MO (PRWEB) November 21, 2014 ... Melancholy Lift, an industry leader in the ... people have significant feelings of sadness and depression ... from traditional pharmaceutical choices. Often, prescription drugs can ... depression. Prescription drugs are expensive and require regular ...
(Date:11/21/2014)... Florida (PRWEB) November 21, 2014 Nature’s Sleep is ... Sleep contest . The contest calls for the creation of any ... a photo — that encompasses sleep, a bed or a mattress. ... year,” said Alan Hirschhorn, Vice President of Marketing for Nature’s Sleep, ... an array of more than 10,000 creative entries from some very ...
(Date:11/21/2014)... people with cochlear implants experience pain, discomfort and problems ... MRI scan, a new study finds. According to ... worldwide have cochlear implants, devices which provide a sense ... severe hearing loss. There have been prior reports of ... One expert said the problem is well-known among ...
(Date:11/18/2014)... 18, 2014 SnapMade , a ... for shoppers in this holiday season, celebrates the oncoming ... Commenting on the launch, Carl Beleek, Group Managing Director ... their customers both old and new in supporting them ... this opportunity to launch new ornaments to better serve ...
Breaking Medicine News(10 mins):Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 2Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 3Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 4Health News:Anacapa Dental Art Institute Prosthodontists Develop New Technique to Offer Younger Appearance in Just One Visit 5Health News:Depression Relief Product Receives Top 5-Star Rating from TopConsumerReviews.com 2Health News:Nature’s Sleep Kicks Off their 2nd Art Of Sleep Contest 2Health News:MRI Can Be Painful, Disruptive for People With Cochlear Implants 2Health News:SnapMade Celebrates Christmas With Exciting New Launches 2
... NEW YORK, February 22 NexGen Biofuels Ltd.,(NASDAQ: ... its symbol to,"NXGN"., The company has changed its ... HCTL to NXGN, to more clearly reflect its new ... and to produce such,fuel through the acquisition of existing ...
... MELVILLE, N.Y., Feb. 22 /PRNewswire-FirstCall/-- Gentiva Health,Services, Inc. ... of,comprehensive home health and related services, announced today ... to 3:55 p.m. ET, Monday, March 3, 2008,at ... in,Orlando, Florida., The event will be available ...
... Calif., Feb. 22 Sutter Health is creating ... care and specialist,physicians committed to providing patients with ... The Sutter Medical Network,will have a presence in ... from Sonoma County to the Central Valley and ...
... Inclinix, Inc., an enrollment,contract research organization (CRO) and provider ... its,executive management team:, -- Steven M. Agnoff, has ... President of Marketing and Product Management. In this ... to the corporate marketing and product ...
... Physicians Coalition,for Injectable Safety has issued a statement ... after reports of serious complications,following treatment with Botox ... Botox(R) injections for cosmetic indications or,who are considering ... recent reports of adverse events, but must put ...
... IT, Sales and Large-Project Management ... Provider,s Partner Channel, BLOOMFIELD HILLS, Mich., Feb. ... (EHR) software and practice,management solutions provider serving healthcare ... has joined,gloStream,s executive management team as chief channel ...
Cached Medicine News:Health News:Gentiva(R) Health Services to Present March 3rd at Raymond James' 29th Annual Institutional Investors Conference in Orlando 2Health News:Gentiva(R) Health Services to Present March 3rd at Raymond James' 29th Annual Institutional Investors Conference in Orlando 3Health News:Sutter Health Launches Northern California Physician Network 2Health News:Sutter Health Launches Northern California Physician Network 3Health News:Inclinix, Inc. Announces Executive Management Team Changes 2Health News:Clarity for Consumers on Botox Complication and Death Reports 2Health News:Clarity for Consumers on Botox Complication and Death Reports 3Health News:Clarity for Consumers on Botox Complication and Death Reports 4Health News:Nationally Recognized Information Technology Veteran and Entrepreneur John Bamberger Joins gloStream, Inc. as Chief Channel Officer 2
Disposable tracheostomy care tray....
Disposable tracheostomy care tray....
... Solution For Your Tracheostomy Care Needs, ... features the latest components for efficient and ... task. Designed by clinicians, these latex-free trays ... patient and caregiver. All of our trays ...
... and alternate care facilities with a ... which offer the finest in nursing ... the guidance of experienced nursing personnel, ... what is required for efficient and ...
Medicine Products: