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Press Release: FDA 510(k) Clears First-Of-Its-Kind API

IT Synergistics Set to Market bexWISE API for Data Exchange Use in Blood Transfusion Medicine and Biologics

IT Synergistics is excited to announce the successful launch of its innovative 510(k) cleared application programming interface (API), a project nearly a year in the making. bexWISE API has met the requirements necessary to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device used along with software applications and web products that support blood bank and other related healthcare facilities.

For its intended use, this API facilitates communication between 510(k) cleared Blood Establishment Computer Systems (BECS) – such as IT Synergistics’ own bexWISE solutions interacting with third-party vendor products– allowing the exchange of donor and donation related data. Through API calls, the requested data once retrieved can help users make essential determinations such as donor eligibility and donation suitability.

As President and CEO of IT Synergistics, Tim Bryant, observed, “This achievement underscores our commitment to advancing technology and delivering solutions that empower our users with seamless, reliable data integration. Our team’s dedication to quality and precision throughout this development process has been vital to our success.”

Manufactured by IT Synergistics, bexWISE API (v1.0) received approval from the FDA as a 510(k) cleared software-only medical device accessory in October 2024. This device includes a user-friendly web portal that enables users to monitor transferred data and identify any errors or warnings encountered due to an API call.

About IT Synergistics

IT Synergistics (ITSy) is a customer driven, 510(k) approved blood establishment computer system (BECS) and CRM vendor. Based upon an ongoing review of member blood centers’ strategic plans and initiatives, ITSy’s customers identify, prioritize, and recommend strategic additions to ITSy’s overall portfolio. IT Synergistics is committed to meeting blood centers’ software needs through a diverse product suite, including its latest offerings, bexWISE Engage and bexWISE API.

Contact: Tim Bryant, President and CEO, tim@itsynergistics.com

adobe_pdf_file_icon_24x24  Press Release – FDA 510(k) Clears bexWISE API (11/05/2024)