SynGen Inc., of Sacramento, CA, maker of products for extracting stem cells from a variety of sources, received FDA clearance for its SynGenX-1000 platform that’s used to harvest stem cells from umbilical cord blood. The individual products include the SynGenX-1000 System comprising of a Control Module, Docking Station, and a Disposable Cartridge (pictured), the CryoPRO-2 Cryopreservation/Storage Bag Set, and SynGen DataTrak software.
Philip Coelho, CEO of SynGen, said in a statement, “This ‘next generation’ SynGenX™-1000 System improves the recovery of stem and progenitor cells from cord blood units, which should increase the number of clinical grade units available for transplantation. The CryoPRO-2™ simplifies the cryopreservation workflow for cord blood bank personnel and provides a medical record of the process. The SynGen™ DataTrak software captures the data associated with processing each cord blood unit for the blood bank’s records.”
Product page: SynGenX-1000 Platform…
Press release: SynGen Inc. Receives FDA 510K Clearance to Market SynGenX™-1000 Cord Blood Processing Platform