Navigation Links
SynGen Inc. Receives FDA 510K Clearance to Market SynGenX-1000 Cord Blood Processing Platform
Date:7/15/2013

SACRAMENTO, Calif., July 15, 2013 /PRNewswire/ -- SynGen Inc., a company focused on the development and commercialization of medical systems that harvest stem and progenitor cells from umbilical cord blood, bone marrow, peripheral blood, and other tissues, announced today that it has been granted FDA 510(k) clearance to market its three related products to process cord blood:

  • SynGenXTM-1000 System: A programmable Control Module, Docking Station and Disposable Cartridge for harvesting stem and progenitor cells from units of collected cord blood. These cells are used to reconstitute the hematopoietic system of patients afflicted with hematologic malignancies such as leukemia and lymphoma and more than 70 genetic diseases.
  • CryoPRO-2TM Cryopreservation/Storage Bag Set: A disposable processing set with a chamber into which the harvested stem and progenitor cells from the SynGenXTM-1000 are transferred, mixed with cryoprotectant and transferred under sterile conditions into a multiple compartment bag for freezing and storage at liquid nitrogen temperatures (-196o C).
  • SynGen™ DataTrak software: The application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the SynGenX™-1000 Control Module and stores it in a database on the host PC computer.

Earlier, the Company was awarded an ISO 13485:2003 Certificate of Registration and a Full Quality Assurance certificate by the British Standards Institution (BSI), which allows it to CE mark its own Class 1 products and commercialize them in the European Union (EU).

Philip Coelho, SynGen's CEO noted: "We thank the FDA for guiding us through the 510(k) clearance process. SynGen is dedicated to developing products
'/>"/>

SOURCE SynGen Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Abbott Announces Collaboration with Syngene to Open First Nutrition R&D Center in India
2. Bison Stainless Tube Receives ISO 9001:2008 Certification
3. UCBs Kremers Urban Pharmaceuticals Inc. receives FDA approval for extended release methylphenidate hydrochloride
4. Society for Clinical Research Sites Receives Unprecedented Response from Industry Stakeholders to Support Sites by Joining Corporate Partnership Program
5. Prime Therapeutics receives prestigious Silver Anvil Award from Public Relations Society of America
6. HeartWare Receives Conditional Approval From FDA to Enroll Supplemental Patient Cohort in Destination Therapy Trial
7. Micell Technologies Receives CE Mark Approval for MiStent SES
8. Prime Therapeutics receives highest rating in 2013 customer satisfaction survey
9. KemPharm, Inc. Receives Patent from the USPTO for Novel Pain Drug Candidate, KP201
10. ViroPharma Receives Orphan Drug Designation For Maribavir In Europe
11. Actinium Pharmaceuticals, Inc. Receives $3.5m from Exercise of Warrants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/2/2015)... BGI a annoncé aujourd,hui que son ... situé à Hong Kong ... Pathologists  (Collège des pathologistes américains, ou CAP). Les ... constituent le premier laboratoire clinique de ... du CAP en Chine, car il satisfait les ...
(Date:7/2/2015)... FORT LAUDERDALE, Fla. , July 2, 2015 ... & Co., is pleased to announce that its ... Inc. ("Insight Beverages") to Kerry Group plc (ISE: ... focused on taste and nutrition systems, as well ... food, beverage and pharmaceutical markets. Farlie Turner served ...
(Date:7/2/2015)... 26, 2015 Research and Markets( ... D Market by Analog, Application, End-User & by Region - ... offering. This market is projected to reach about ... in different applications and rising opportunities in countries such as ... Italy , and Brazil ...
Breaking Medicine Technology:BGI obtient la certification du Collège des pathologistes américains (CAP) 2Farlie Turner's Consumer Group Completes Sale of Insight Beverages to Kerry 2Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 2Vitamin D Market by Analog, Application, End-User & by Region - Global Trends & Forecast to 2020: Increasing Recommendation By Doctors & Associations 3
(Date:7/3/2015)... ... July 03, 2015 , ... ... healthcare providers, has been retained to lead a national chief nursing officer ... top-ranked executive search firms in the healthcare industry, B. E. Smith has recently ...
(Date:7/3/2015)... ... 2015 , ... First Choice Emergency Room , the largest network of ... the new Medical Director of its Frisco facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:7/2/2015)... ... July 02, 2015 , ... sweetFrog Enterprises, LLC. is pleased to ... the first sweetFrog store located in Mississippi. The premium frozen yogurt chain was listed ... The store, located at 104 Railroad Avenue, New Albany, MS 38652, will have a ...
(Date:7/2/2015)... ... July 02, 2015 , ... When Walker ... at the University of Minnesota, they knew it would save the university energy ... an award-winning choice: the total energy savings after installation was an impressive 89 ...
(Date:7/2/2015)... ... July 02, 2015 , ... As Americans celebrate the Fourth of July ... cancer is on the rise. July is UV Safety Month, and physicians at American ... importance of getting skin checks. Experts say most skin cancers can be found early ...
Breaking Medicine News(10 mins):Health News:Jane Phillips Medical Center Retains B. E. Smith to Recruit New Chief Nursing Officer 2Health News:Jane Phillips Medical Center Retains B. E. Smith to Recruit New Chief Nursing Officer 3Health News:First Choice Emergency Room Announces Dr. Mariah N. Manzanares as Medical Director of Frisco, TX Facility 2Health News:First Choice Emergency Room Announces Dr. Mariah N. Manzanares as Medical Director of Frisco, TX Facility 3Health News:sweetfrog Opens First Location in Mississippi 2Health News:Kenall’s TekDek™ Helps University Achieve Award-Winning Energy Savings in Parking Structure Lighting Retrofit 2Health News:Local Physicians Warn of Holiday Health Hazards 2Health News:Local Physicians Warn of Holiday Health Hazards 3Health News:Local Physicians Warn of Holiday Health Hazards 4
... WINSTON-SALEM, N.C. Sept. 16, 2011 A study ... colleagues suggests that a high intake of calcium causes ... absorbers of the mineral. "High dietary intake of ... the explanation for this observation has been elusive," said ...
... THURSDAY, Sept. 15 (HealthDay News) -- The rate of new lung ... as it has for men in for years, a new U.S. ... 2.2 percent per year on average for women between 2006 and ... 2006, according to the U.S. Centers for Disease Control and Prevention. ...
... speaking on Capitol Hill today demonstrated that the Great ... older workers, although programs such as the federal Senior ... some valuable benefits to this disadvantaged demographic group. ... of National Employ Older Workers Week was titled, ...
... of young children admitted to hospitals or seen in ... dose of medication has risen dramatically in recent years, ... study. The rise in exposure to ... for Disease Control and Prevention has established the PROTECT ...
... Alzheimer,s diagnosis presents new challenges to the public, physicians and ... you want to know? How should doctors tell you your ... diagnosed Americans still in the workplace? Despite the ... effective interventions have been identified to stop the progression of ...
... , THURSDAY, Sept. 15 (HealthDay News) -- Men and women ... their eyelids appear to face a higher risk of heart ... new Danish research suggests. The link between the skin ... rather than a clear case of "cause and effect." ...
Cached Medicine News:Health News:Genetics may explain why calcium increases risk for prostate cancer 2Health News:Lung Cancer Rates Begin to Decline for U.S. Women 2Health News:Congressional briefing sheds light on poor seniors' employment struggles 2Health News:Congressional briefing sheds light on poor seniors' employment struggles 3Health News:Number of children poisoned by medication rising dramatically, study says 2Health News:Safeguards needed to prevent discrimination of early Alzheimer's patients in the workplace 2Health News:Cholesterol Deposits Around Eyes Linked to Heart Risk 2
... Complete procedure information to facilitate diagnostic ... monitor is a sterile, disposable device used ... nucleus during discography procedures. The device will ... display it in a digital format. The ...
Smith & Nephew's CDS System is developed exclusively for discography., Developed exclusively for discography, it is the first system designed to measure true disc pressure and record real-time proce...
The ACCU-DISC™ pressure monitoring system offers the advantage of accurate delivery of fluids to the body with the ability to monitor the pressure of those fluids in discography interpretation....
The °CureWrap is one-piece garment offers maximum available surface coverage, while avoiding the sterilized fields of operation....
Medicine Products: