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:7/23/2014)... 2014  When it comes to welcoming our new robot ... roll out the red carpet. Healthcare is one ... 9000-like robots into our human sphere. With healthcare concerns top ... need to apply new technologies to help with old problems. ... robotics is expected to increase from $1.7 billion now to ...
(Date:7/23/2014)... 23, 2014  Nearly 8,000 attendees will converge in ... annual Retail Business Conference (RBC), taking place July 23-26 ... year,s event encourages pharmacists to "Lead Change" in the ... for their future. "RBC is ... with their peers and learn new ways they can ...
(Date:7/23/2014)... 23, 2014  Cardica, Inc. (Nasdaq: CRDC ) ... fiscal fourth quarter and year ended June 30, 2014, on ... will host a conference call at 4:30 p.m. Eastern Time ... the company,s business. Conference Call Details To access ... p.m. Eastern Time via phone, please dial 866-953-6859 from ...
Breaking Medicine Technology:Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 2Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 3Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 4Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 5Cardinal Health Encourages Independent Pharmacists to Lead Change at 24th Annual Retail Business Conference 6Cardica to Announce Fiscal 2014 Fourth Quarter and Full Year Financial Results on Thursday, August 7, 2014 2
... 2011 Pharmatek Laboratories, Inc., a premier contract ... announced that it has added spray drying to ... has purchased a Buchi B-290 Mini Spray Dryer ...  This technology can be used for both oral ...
... (NASDAQ: STXS ) today announced that executive management ... The Deutsche Bank Annual Health Care Conference ... of Stereotaxis, is scheduled to present an overview of the ... The JMP Securities Annual Research Conference in San Francisco. ...
Cached Medicine Technology:Pharmatek Laboratories Adds Spray Drying to Drug Development Services 2Stereotaxis to Present at Upcoming Investor Conferences 2Stereotaxis to Present at Upcoming Investor Conferences 3
(Date:7/23/2014)... voice on the recording was low and calm as the speaker ... with the human immunodeficiency virus (HIV) that causes AIDS: “My heart ... I was on the floor flat on my face boohooing, crying ... recording ended less than 10 minutes later. “Don’t feel like this ... is just God setting you up for something greater,” the anonymous ...
(Date:7/23/2014)... By Kathleen Doheny ... (HealthDay News) -- Weight-loss surgery appears to have an ... symptoms in women, according to a new study. ... a weight-loss surgery program reported having incontinence prior to ... their urinary symptoms either improved or disappeared, said study ...
(Date:7/23/2014)... By Amy Norton ... -- The timing of a girl,s first menstrual period may ... a new study suggests. Researchers have identified over ... of menarche -- a woman,s first menstrual period. The researchers ... a number of diseases ranging from type 2 diabetes to ...
(Date:7/23/2014)... genes have been focused on the regions of the ... the form of amino acids thus proteins. But just ... activator which controls the expression and activity of the ... the role exerted such DNA fragment in tumor development. ... in collaboration with the group of Manel Esteller, ...
(Date:7/23/2014)... likelihood of forming false memories, according to research published ... Association for Psychological Science. , In a study conducted ... of California, Irvine and colleagues, sleep-deprived people who viewed ... false information about the photos were more likely to ... were those who got a full night,s sleep. , ...
Breaking Medicine News(10 mins):Health News:HIV clinic-based audio project emphasizes the power of patient voices 2Health News:HIV clinic-based audio project emphasizes the power of patient voices 3Health News:Weight Loss Surgery May Help Ease Urinary Incontinence 2Health News:Weight Loss Surgery May Help Ease Urinary Incontinence 3Health News:Gene Study Gives New Insight Into Puberty in Girls 2Health News:Gene Study Gives New Insight Into Puberty in Girls 3Health News:Sleep deprivation may increase susceptibility to false memories 2
... Hospitals that have better working conditions for nurses are ... to a recent report , led by researchers ... are the number six cause of death in the ... workforce in the nation's hospitals, are in a unique ...
... claimed to have developed super-oxidised water, which speeds up ... is made by passing it through a salt membrane ... fungi. ,The company claims that the solution ... ,We would welcome any safe effective treatment which could ...
... has found how medical science could employ aspirin and ... in certain high-risk individuals. ,The study ... Sanford Markowitz at the Ireland Cancer Center. ... mechanism by which the use of aspirin and nonsteroidal ...
... Army hospital here has conducted an accident victim's multiple organ ... to three individuals. ,The retrievals were conducted ... and the organs were transplanted Thursday on two patients at ... ,Donor Ramesh Chand, 60, whose two sons serve ...
... their birth, healthy babies will look you in the eye. ... 9 months, they will exchange smiles. If they ... to worry. ,There is a growing field ... increasingly looking for early signs in babies of autism, attention ...
... Chinese exporters. After the furore over pet food, it is ... under the scanner. ,The federal government has announced ... Food and Drug Administration decides whether the product contains diethylene ... fluid. ,The imports will be released only if ...
Cached Medicine News:Health News:Better Working Conditions for Nurses Might Decrease Patient Infections 2Health News:Better Working Conditions for Nurses Might Decrease Patient Infections 3Health News:Aspirin may Help to Prevent Colon Cancer in High-risk Individuals 2Health News:Army Hospital Conducts First Multiple Organ Retrieval and Transplantation 2Health News:Watch Out for Signs of Autism in Babies! 2Health News:Watch Out for Signs of Autism in Babies! 3Health News:US Halts Import of Chinese Toothpaste 2
All the power and performance of the STS - T but now available with a stand-alone 9" II C-Arm...
... SL1 developed by STORZ MEDICAL is the ... in the field of kidney stone lithotripsy ... requirements to be met by orthopaedic apparatus ... been outlined above. The MINILITH SL1 is ...
... transportable, the Dornier Compact Delta lithotripsy system features ... patient. The systems shock source and C-arm are ... avoid the risk of misalignment. The therapy head ... its motorized lateral and horizontal movement and can ...
Used for temporary urine collection. The leg bag is designed for use with the Non-Adhesive Silicone Condom Catheter. Supplied non-sterile. Reusable. Intended for single patient use only....
Medicine Products: