Navigation Links
Celsense, Inc Files FDA & EMEA Regulatory Submissions
Date:10/12/2009

Click( this.href );" target="_blank" title="Cell Sense in clinical use">Cell Sense in clinical use.

“Several customers are now planning to incorporate the use of Cell Sense in new and existing INDs,” stated O’Hanlon, “and having a DMF/ASMF for them to reference will encourage product adoption, shorten the qualification process for customers, and meet our corporate goal of having the first imaging reagent formally approved for non-invasive, human clinical in vivo tracking of therapeutic and diagnostic cells.”

In October 2007, the U.S. FDA concluded, in response to the company’s request for designation, that Cell Sense is a drug that will be reviewed and regulated by the Center for Biologics Evaluation and Research (CBER) under the new drug provisions of the Federal Food, Drug, and Cosmetic Act (the Act).

Cell Sense is a fluorocarbon ex vivo cell label that enables investigators and clinicians the ability to non-invasively track the therapeutic and diagnostic cells in vivo using Magnetic Resonance Imaging (MRI). The emulsion is a self-delivering nanoparticle that requires no exogenous transfection agent and is stable at lysosomal pH levels within the cell. Cell Sense emulsion enables investigators the ability to identify, quantify, and follow pre-labeled cells in vivo using fluorine (19F) magnetic resonance imaging (MRI) technologies.

Celsense, Inc. has three reagents for MRI imaging of cells currently on the market for pre-clinical research and discovery. The company also offers Voxel Tracker workstation software that maximizes the Cell Sense MRI data set. Customers include leading pharmaceutical and biotechnology companies and medical research centers worldwide.

About Cell Sense
Cell Sense is a fluorocarbon tracer agent used to
'/>"/>

Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Pan-American Life Insurance Group Plans to Complete Coverage in Central America With Entry Into Costa Rica; Company Files Request for Authorization
2. Profiles International Finds High Employee Utilization is One Key to Maximizing Productivity
3. Reportlinker Adds H1N1 (Swine Influenza) Market Assessment (Latest Data, Company Profiles, Implications for Immunoassays and Molecular Assays) Report
4. Texas Doctor Files Case Pro Se in U.S. Supreme Court Against Insurance Giant on Integrity and Unethical Practices
5. Innovative Medical Technology Companies From Around the World Selected to Present Profiles to Industry Leaders & Financiers at AdvaMed 2009
6. Warner Chilcott Files New Lawsuit for Infringement of LOESTRIN(R) 24 FE and FEMCON(R) FE Patents
7. GENova files patent for new breast cancer treatment
8. Longevinex(R) Files Lawsuit Against ResveratrolBenefits.com, for False and Misleading Statements
9. US Farms, Inc. Files Trademark Application for Aloe365
10. Genova files patent for new prostate cancer treatment
11. Sun Pharmaceutical Files HSR Application for Taro Tender Offer
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Celsense, Inc Files FDA & EMEA Regulatory Submissions
(Date:7/2/2015)... ... ... In 2012, Patrick Achebe realized that the gift of poetry was fully in him, as ... first poem, and three years later he was publishing an entire book of poetry. He ... world. "I have always believed that the best way to lift yourself up, is in ...
(Date:7/2/2015)... ... July 02, 2015 , ... ... of the SIGVARIS PERFORMANCE SOCKS. Since the socks were first introduced, they have ... Their significant popularity has inspired four new, fun shades including: blue, lime, pink ...
(Date:7/2/2015)... (PRWEB) , ... July 02, 2015 , ... The ZAC ... the 2015 swim season with important lessons on how to stay water safe with ... Who Couldn’t, Wouldn’t Swim, authored by The ZAC Foundation co-founders, follows Zeke’s water safety ...
(Date:7/2/2015)... Dallas, TX (PRWEB) , ... ... ... “Negative pressure wound therapy (NPWT) - pipeline review 2015” provides comprehensive information ... stages of development. Complete report on negative pressure wound therapy (NPWT) with ...
(Date:7/2/2015)... ... July 02, 2015 , ... Facial plastic surgery ... precision. There is an art and science that goes into successful facial reconstruction ... the facial features and lives of more than 2,500 satisfied facelift and neck ...
Breaking Medicine News(10 mins):Health News:Patrick Achebe Releases Debut Book, Whispering Waves: Poems for Everyday Grace 2Health News:SIGVARIS is Sporting Four Brand New Colors in the Popular PERFORMANCE SOCK Product Line 2Health News:The ZAC Foundation Kicks Off Summer and July 4th Weekend with Complimentary Children’s E-Book on Water Safety 2Health News:The ZAC Foundation Kicks Off Summer and July 4th Weekend with Complimentary Children’s E-Book on Water Safety 3Health News:Negative Pressure Wound Therapy (System, Wound Care, Tissue Cooling NPWT) Pipeline Review 2015 Market Research Report Available at RnRMarketResearch.com 2Health News:Negative Pressure Wound Therapy (System, Wound Care, Tissue Cooling NPWT) Pipeline Review 2015 Market Research Report Available at RnRMarketResearch.com 3Health News:Negative Pressure Wound Therapy (System, Wound Care, Tissue Cooling NPWT) Pipeline Review 2015 Market Research Report Available at RnRMarketResearch.com 4Health News:Dr. Kevin Sadati Featured in July Issue of Popular National Magazines 2Health News:Dr. Kevin Sadati Featured in July Issue of Popular National Magazines 3
... Wednesday, May 7, Cedar,Point amusement park/resort will host the ... this special event will benefit the,Firelands Chapter of the ... at Cedar Point,s Challenge Park and will,be a four-person, ... shotgun start at 4:30 p.m. Teams of four can ...
... are highly effective at preventing acute respiratory illness and ... worse, according to research published in the April issue ... , A study of 87 patients with chronic obstructive ... health and death - found that having the annual ...
... CDI Program Utilizing the Expertise of Two Industry ... ... 15 Precyse Solutions, the leader in,driving peak performance within Health ... robust service,offerings and highly qualified team of HIM experts. Noted professionals ...
... Cynosure, Inc.,(Nasdaq: CYNO ), a leading ... aesthetic treatment systems, today announced that the company,will ... April 29, 2008,at 9:00 a.m. ET., On ... Davin and,Executive Vice President and Chief Financial Officer ...
... Benefits of Healthy, Wholesome Foods, JACKSONVILLE, Fla., April ... including those among children -- are at an all-time ... nutritional,information aimed at helping the youngest members of society ... resources like these,are few and far between., But ...
... they are to undergo screenings , , TUESDAY, April 15 ... women perceive their cancer risk may influence how likely ... cancer, says a University of California, San Francisco study. ... to 80, about breast, cervical and colon cancer. The ...
Cached Medicine News:Health News:Flu vaccines can reduce respiratory problems by up to 3/4 2Health News:Flu vaccines can reduce respiratory problems by up to 3/4 3Health News:Precyse Solutions Launches Clinical Documentation Improvement Program to Assist Hospitals in Accelerating Revenues 2Health News:Cynosure to Announce First-Quarter 2008 Financial Results on April 29 2Health News:Professor Woodpecker Makes Children's Nutrition Fun and Simple 2Health News:Professor Woodpecker Makes Children's Nutrition Fun and Simple 3Health News:Women's Awareness of Cancer Risk Linked to Race, Ethnicity 2
(Date:7/2/2015)... 25, 2015 ... the addition of the "2015 New ... Challenges, Emerging Technologies, Competitive Landscape" report ... Frontiers in Clinical Chemistry and Immunodiagnostics: Global ... new seven-country strategic analysis of major business ...
(Date:7/2/2015)... 2 de julio de 2015 BGI anunció ... de alto rendimiento en Hong Kong ... of Pathologists (CAP). La instalación de BGI en ... secuenciación de próxima generación que recibe la certificación CAP ... alto estándar en prácticas de laboratorio clínico. Junto con ...
(Date:7/2/2015)... July 2, 2015 ALPINION MEDICAL SYSTEMS Co., ... Series ultrasound system. Developed to enhance user experience and ... E-CUBE 15 EX produces superb image quality. With advanced ... women,s health, general imaging, and shared service applications. ... in the renowned E-CUBE Series, the E-CUBE 15 EX ...
Breaking Medicine Technology:New Frontiers in 2015 Global Clinical Chemistry and Immunodiagnostics Market: Challenges, Emerging Technologies, Competitive Landscape 2BGI recibe la acreditación del College of American Pathologists (CAP) 2E-CUBE 15 EX from ALPINION Enhances User Experience and Patient Care 2E-CUBE 15 EX from ALPINION Enhances User Experience and Patient Care 3
... Abaxis, Inc. (NasdaqGS: ABAX), a medical products company manufacturing ... chairman and chief executive officer, will present at CL ... September 14, 2011 at 9:00 a.m. ET. The conference ... in New York City. About Abaxis ...
... 2011 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX ... and commercialization of innovative therapies for the treatment of ... President and Chief Executive Officer, will present at the ... NY at The Waldorf Astoria. The presentation is scheduled ...
Cached Medicine Technology:Abaxis, Inc. to Present at CL King's 9th Annual Best Ideas Conference 2011 2AcelRx Pharmaceuticals to Present at the Rodman & Renshaw Global Investment Conference 2
... SheerVision manufactures its signature line ... are available in a lightweight, yet ... loupes feature extremely high resolution razor-sharp ... are multi-coated lens for anti-glare, anti-fog, ...
... SheerVision is now the first ... loupes directly to the wearer. These ... resolution razor-sharp clarity, an ultra-lightweight design, ... anti-fog, and scratch resistance. With SheerVision's ...
Easy pull-on garment's feature Rainey's exclusive Non-Slip Dome™design and adjustable Velcro© closure at neck for optimal comfort and support. Choose covered or non covered ear design....
Facial Wrap...
Medicine Products: