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Jun 03, 2013

iTrace for Blood Centers receives FDA 510(k) clearance
Source: S3Edge

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.

 

S3Edge, Inc. welcomes the announcement by the Food & Drug Administration (FDA) that iTrace for Blood Centers, the tracking system developed by the RFID Consortium has been cleared for marketing. The RFID and barcode based Blood Product Tracking system enables improved compliance with FDA tracking requirements for blood products, enables cross hospital inventory optimization to reduce waste from outdated products and improves patient safety by preventing the release of unsuitable blood products. The RFID Consortium includes BloodCenter of Wisconsin, SysLogic, Inc., S3Edge Inc., Carter Bloodcare, Mississippi Blood Services, the University of Iowa Hospitals and Clinics (UIHC), Mississippi Baptist Health System, University of Wisconsin Madison - RFID Laboratory, and Mediware Corp.


"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 through distribution".


"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 suite of mobile, desktop and server software applications was deployed in production pilots at the BloodCenter of Wisconsin and the DeGowin Blood Center at UIHC where it was run in parallel with IPR, an internally developed barcode-based tracking system. "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.



About BloodCenter of Wisconsin
As a pioneering leader in science and medicine, BloodCenter of Wisconsin contributes to the discovery, diagnosis, treatment and cures for patients like no other single organization can by virtue of the expertise, diversity and innovation that reside within each of its service areas. BloodCenter of Wisconsin collects and distributes life-saving blood and marrow for Wisconsin families and tissue and organs for southeastern Wisconsin families. A private, not-for-profit organization, BloodCenter of Wisconsin also specializes in diagnostic testing, medical services, and leading-edge basic and clinical research. For more information, visit www.bcw.edu


About University of Iowa Hospitals and Clinics
University of Iowa Hospitals and Clinics is Iowa's only comprehensive academic medical center and a regional referral center. UI Hospitals and Clinics and UI Children's Hospital together deliver quality care in collaboration with University of Iowa Physicians, the state's largest multi-specialty medical and surgical group practice composed of faculty physicians of the UI Roy J. and Lucille A. Carver College of Medicine. Together, these partners work together as University of Iowa Health Care to provide patient care, conduct biomedical research, and train the next generation of health professionals. Learn more at uihealthcare.org.



About SysLogic, Inc.
SysLogic, Inc. is a Brookfield, Wisconsin-based information systems consulting and services firm dedicated to helping clients conduct business more effectively by delivering proven and emerging process and technology solutions. Learn more at www.syslogicinc.com



About S3Edge, Inc.

S3Edge is a software product company that provides packaged, Auto-ID-based tracking solutions for automation and error proofing of supply chain operations. Spotlight, S3Edge's software product enables enterprises to configure and view assets, zones, alerts, and reports and to track and obtain trends on asset movement within their organizations. For more information, visit www.s3edge.com.


Contact Information
Mark Anastas
S3Edge Inc
www.s3edge.com
5038479450

 
 

To get more information about how the S3 RTVS portfolio of solutions enable significant improvements to your business processes in a rapid manner without having to invest heavily upfront, please e-mail us at info@s3edge.com.

 
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Daniel Bowman
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"We selected S3Edge after evaluating solution providers based on their experience, and ability to deliver a mission-critical, large-scale enterprise application focused on the operator and the flow of work in our existing processes. Thanks to this approach and S3Edge's focus on delivering to commitments, the project benefits were realized within three months of launch with little to no re-engineering required. The system has been running live in a high velocity, dynamic manufacturing environment for over a year with no issues"

Balaji Suresh
Materials Manager, and project sponsor
United Technologies

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We are extremely pleased to team up with S3Edge to put this exciting system development into the hands of our clients. Our unified, best-of-breed approach, which brings together Access Solutions’ deep domain expertise in the FME industry and S3Edge’s Spotlight technology for RFID-based asset tracking, as well as their systems integration bench strength and expertise, will deliver unparalleled levels of efficiencies across the enterprise

Kelvin Mann,
President  & CEO, Access Solutions

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The S3Edge's RTVS based WiP (work in process) solution delivered on the promise of real visibility, real time in record time to enable GKB (Carl Zeiss Vision JV partner) to continue to raise the bar in the level of service .The WIP solution was delivered at ZEISS Brand Lab at Goa (a Carl Zeiss "Star One" accredited lab). In addition to enabling fewer delayed orders, and a multi-fold increase in customer satisfaction with a RFID based solution on the manufacturing floor, S3 is also closely working with us on designing innovative solution for our retail stores in India to further increase our customer value.

Manish Soni
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S3 Edge’s unique capabilities and deep understanding of Microsoft’s Mobile RFID platform was crucial in deploying a turnkey solution at RiteCare pharmacy for warehouse visibility – their ability to go from design to fully operational in 60-90 days at the customer site is a testament of their abilities to show demonstrable ROI and lower the barrier to rapid solution deployment.

Judy Huang
Product Manager RFID
Unitech Electronics Co., LTD

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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 from the hospital blood bank to the point-of-care and in remote storage in our emergency department.

Dr. Thomas J. Raife,
MD, Clinical Professor & Medical Director,
UIHC DeGowin Blood Center

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S3 Edge's RTVS capabilities enabled RiteCare Pharmacy to envision, design and implement game-changing business processes. The S3 Edge RTVS software built on Microsoft BizTalk platform has enabled us to cut down our cycle times to ship by 50%, eliminate errors due to mis-ships, and double our throughput times. This innovative real-time visibility platform for warehouse ensures RiteCare can now scale rapidly in the future to fulfill our promise of a quality pharmacy in every neighborhood with wide variety of medicines.

Seshu Guddanti
Managing Director of RiteCare

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"S3Edge is a key partner in developing packaged solutions that fully utilize the capabilities of the Microsoft BizTalk RFID platforms to address real-world customer need. Their Spotlight product is a good example of how partners are innovating to deliver complete end-to-end solutions for customers on the Microsoft Application Platform, across the globe"

Sudhir Hasbe

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Thanks to the outstanding work of the entire consortium team, we have successfully piloted the new system to track blood products as they move from fixed and mobile donation sites, through the blood center and to distribution. After 24 weeks of running the system in a pilot mode here at the BloodCenter of Wisconsin, we have seen process efficiency and traceability gains, as well as marked improvements in reconciliation

Lynne Briggs
Vice President and
Chief Information Officer,
Blood Center of Wisconsin, Milwaukee

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S3Edge's packaged asset tracking software has enabled us to go from assessing technical feasibility to building out a set of applications that address the operational needs of blood centers and hospitals in a relatively short period of time. Their technical abilities and experience in deploying enterprise-ready applications has helped the consortium deliver on the promise of a packaged mission critical solution to improve the safety and efficiency of our nation's blood supply


Tina Chang
CEO, SysLogic Inc.

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S3Edge has helped Motorola take our partnership with Microsoft BizTalk RFID to the next level.

Matt Eschbach
Global Strategic Alliance Manager
Motorola Enterprise Mobility Business

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"S3Edge's commitment to quality, flexibility, and RFID domain expertise in deploying enterprise-ready software in an operationally challenging environment using a variety of devices, is second to none. Their approach to deploying a scalable Real-Time Visibility & Control System has allowed us to take a complex, emerging technology and convert it into a competitive advantage for our business and customers"

James Chan
General Manager

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S3Edge continues to raise the bar in the area of software innovation to address customer needs. The support for Android-based devices for our transfusion medicine RFID applications will give healthcare professionals in our field an easy, well-understand interface to quickly adopt a new set of auto-ID applications aimed at cutting costs and eliminating errors in the blood supply chain. This new-paradigm is going to be the game-changer in the adoption of RFID based applications in Healthcare.

Clive Hohberger
RFID Systems Architect,
Blood Center of Wisconsin

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We are extremely pleased to team up with S3Edge to design, and develop this innovative application for the transfusion medicine industry. Our collaborative, best-of-breed approach, which brings together the domain expertise in Transfusion Medicine practices and S3Edge's software strength, will deliver unparalleled levels of efficiencies for blood centers and hospitals across their supply chain operations


Rodeina Davis
Vice-President & CIO, BloodCenter of Wisconsin

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S3 Edge is our most preferred RFID technical partner

Kian NG
SOA, Process Platform & RFID Solutions Sales - ASIA Lead
Microsoft Asia Pacific

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"The expertise and credibility of the S3Edge team made it an easy choice for us to engage with them to build out our device provider capabilities for the BizTalk RFID platform. In addition, their ability to deliver ‘80% done, 20% customizable’ software solutions via their rich RTVS solution framework is a much needed piece of the puzzle in enabling our integrators to deliver high-value, complex solutions in a repeatable cookie-cutter manner, with lesser custom code"

Sal Scafidi
Strategic Business Manager
Omron RFID Division
United Technologies

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  Spotlight based RFID Software provides an automated method of identifying the movement of assets across various locations by deploying a packaged inventory-tracking solution across various devices, that can then be customized for specific business-process workflows.