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:7/31/2014)... , July 31, 2014  Decision Resources ... brought about by the Affordable Care Act ... prescribing of pharmaceutical therapies. The ACA altered ... through new regulations and expanded access via ... the health exchanges—state-based marketplaces set up by ...
(Date:7/31/2014)... , July 31, 2014 Touro University California,s ... been selected as the recipient of a $150,000 grant ... allow the University to increase research and classroom space ... state-of-the-art technology for the study of health sciences, and ... diverse needs and interests of our students," said ...
(Date:7/31/2014)... 31, 2014 For its innovative modular Biomedical ... , Art,s-Way Scientific has earned a Modular Building Institute ... in over 30 categories, MBI,s contest is the commercial ... include building manufacturers, dealers, and product and service providers. ... the capability of our team," said Dan Palmer ...
Breaking Medicine Technology:Health Exchanges Drive Change In MCO Strategies And Physician Prescribing Decisions; Impact On Pharma Mixed 2Health Exchanges Drive Change In MCO Strategies And Physician Prescribing Decisions; Impact On Pharma Mixed 3Health Exchanges Drive Change In MCO Strategies And Physician Prescribing Decisions; Impact On Pharma Mixed 4Touro University California Garners Grant From Long Foundation 2Art's Way Scientific Earns Prestigious Modular Building Institute Award 2Art's Way Scientific Earns Prestigious Modular Building Institute Award 3Art's Way Scientific Earns Prestigious Modular Building Institute Award 4
... Institute, the leading provider of specialized training solutions ... subsidiary of Campbell Alliance, announced today the completion ... Area Essentials™ e-course series.  This series ... biotech R&D and commercial professionals.  It includes 155 ...
... Calif., June 20, 2011 Inogen has been honored ... the Inogen One Portable Oxygen Concentrator.  The Medical Design ... exclusively recognizes contributions and advances in the design of ... by Goleta, California based Inogen, Inc. is used to ...
Cached Medicine Technology:Therapeutic Area Essentials "Class of 2011" Brings Current Disease State Training to Pharma 2Inogen One Wins Gold Medical Design Excellence Award 2
(Date:8/1/2014)... A new study published in ... contribute to the development of colorectal cancer in patients ... study was authored by Alberto Martin of the University ... intestinal cells to multiply and create tumors in mice ... , “What’s interesting about this study,” said Shahab Mehdizadeh, ...
(Date:8/1/2014)... (PRWEB) August 01, 2014 Narconon Arrowhead ... the program at the drug rehab center located in ... year 2001, Narconon Arrowhead is the flagship drug rehab ... across the United States for services there. Now, with ... has recent outcome studies as well as client reviews ...
(Date:8/1/2014)... Albany, New York (PRWEB) August 01, 2014 ... intelligence firm, recently announced the addition of a ... The report, titled ‘Infusion System Market (Large Volume, ... Analysis, Size, Share, Growth, Trends And Forecast, 2013 ... the company’s website http://www.transparencymarketresearch.com . , To ...
(Date:8/1/2014)... By Tara Haelle ... -- A home-packed lunch isn,t necessarily healthier than school cafeteria ... that just 27 percent of the lunches third and fourth ... Lunch Program (NSLP) standards. , , "Our findings are similar ... across the world, which have found that high-calorie packaged foods ...
(Date:8/1/2014)... -- Although older women with asthma often have worse health ... to a new study. "There is no doubt that ... over 65," concluded Dr. James Sublett, an allergist and president-elect ... in an organization news release. In fact, the asthma ... nearly four times higher than in other groups of people, ...
Breaking Medicine News(10 mins):Health News:Carbs May Contribute to Colon Cancer 2Health News:Narconon Arrowhead Celebrates 4,300th Graduate from Program 2Health News:Narconon Arrowhead Celebrates 4,300th Graduate from Program 3Health News:Transparency Market Research Adds Report on Global Infusion System Market to its Repository 2Health News:Transparency Market Research Adds Report on Global Infusion System Market to its Repository 3Health News:Kids' Lunch Boxes Often Fall Short on Nutrition 2Health News:Kids' Lunch Boxes Often Fall Short on Nutrition 3Health News:Older Women With Asthma Face Worse Health Outcomes 2
... to be worst hit by the bird flu, have confirmed ... disease //in Shanxi province on Monday. ,The officials ... identified after an indefinite number of chickens died in poultry ... they have sent the samples of the dead birds to ...
... restrictions that are to be placed on advertising junk food ... games, cinemas, packaging, and school sponsorship. Reports also indicate that ... the use of loyalty cards in store, so that healthy ... contain high levels of salt, fat and sugar. ...
... to a report put forth on ... nursing education of Witwatersrand University, ... to suffer from anemia and elevated ... pregnancy and eventually deliver babies with ...
... new way of freezing human eggs which will be a blessing ... able to have children. , ,Women’s eggs are very delicate ... to sperms which can be easily frozen and thawed. ... researchers which hold promise over the present technique being used. ...
... for health in Andhra Pradesh, the state has recorded the highest ... rate is stuck at 62 per 1000 live births for the ... very slow rate and perhaps will take another decade to touch ... Pradesh back in the achievement of the millennium development goals targeted ...
... in Sydney have identified a cue to detect depth in motion. ... is dynamic //half-occlusion. This is helpful in achieving a perception of ... a free access on Association for Research in Vision and Ophthalmology ... established by Leonardo da Vinci, Drs.Kevin Brooks and Barbara Gillam of ...
Cached Medicine News:Health News:Junk Food Advertisements To Be Restricted In All Forms of Media 2
... The Forceps Are Available In Two Models: ... Are Compressed, The Jaws Close. The Other ... The Handles Are Compressed The Jaws Open., ,The ... To Be Inserted Through A 1.1mm Incision. These ...
... Turned 90 Degrees To Allow Full ... Incising Tissue. ,Special Mirror-Polished Double Footplate Construction ... Extension Settings Of 0.5mm, 0.55mm, 0.6mm, ... Wide Snub Nose Diamond Blade Is ...
2.5V Halogen source, fiber-optic delivery, 2.5X magnification....
2.5V Halogen source, fiber-optic delivery, 3X magnification, pocket-sized....
Medicine Products: