Auto-ID based tracking system developed as a result of a National Institute of Health STTR Grant secures FDA 510(k) pre-market clearance, SysLogic initiates transfer to S3Edge.
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“This effort represents the culmination of years of hard work by Rodeina Davis (principle investigator for the STTR grant, and a luminary in the transfusion medicine field), and the consortium members in bringing a much
needed innovation to the market in a collaborative manner. The FDA 510(k) clearance and commercialization will ensure that the cumulative efforts of the consortium benefit the transfusion medicine industry as a whole”,
said Lynne Briggs VP and CIO at BloodCenter of Wisconsin. “Our pilot of iTrace for Blood Centers showed marked improvements in efficiency and accuracy in reconciling and tracking blood products from collections
“We are happy to now initiate the transfer of the 510K clearance to S3Edge to enable further commercialization of iTrace for Blood Centers. Today’s announcement showcases our commitment not just to create compelling
technology, but to realize the vision of creating a successful product for the transfusion medicine industry” said Tina Chang, CEO of SysLogic, Inc., a Brookfield, Wisconsin-based information systems consulting and
services firm, one of the founding members of the consortium and awardee of the STTR grant.
“The RFID system provided equivalent capabilities to
those of IPR in terms of detecting and resolving process errors. It additionally provided the blood bank staff real-time visibility for blood products in transit to the point-of-care and in remote storage in our emergency department. We are excited by the potential of this technology to further improve transfusion safety in operating rooms because of its hands-free non-invasive nature” said Dr. Thomas J. Raife, MD, Clinical Professor & Medical Director, UIHC DeGowin Blood Center.
“As the exclusive commercialization partner selected by the RFID Consortium, this is an exciting development that enables us to broadly market and deploy iTrace for Blood Centers. We look forward to completing the requirements for the transfer of the 510K from SysLogic and bringing this solution to the market. This significant milestone could not have happened without the efforts, guidance and leadership of the consortium. We look forward to working in tandem with this team of health care stakeholders and distinguished researchers
to ensure Blood Centers around the world can take full advantage of this new system”, said Mark Anastas, President of S3Edge Inc.