StreamPath® Viewer and automated workflow now cleared by European regulations for use in primary diagnostics*
SPOKANE, Wash., October 9, 2022 /PRNewswire/ — Gestalt Diagnostics, Inc., a leading provider of award-winning digital pathology solutions, today announced that it has received CE-IVD marks for two of PathFlow’s core components. PathFlow Viewer and proprietary automated workflows now have European regulatory clearance for wide use in clinical, teaching and research laboratories.
European regulatory certification of these key components of Gestalt’s PathFlow provides the support certain healthcare organizations need to fully deploy and recognize the value of digital pathology across their organizations. Gestalt’s feature-rich viewer is consistent across all PathFlow modules, whether clinical, educational, or research, and provides the pathologist or scientist with access to all information related to their case, study, or course in any environment. unique and streamlined.
“The awarding of the CE mark for the PathFlow Viewer and Pathologist Workflow application in accordance with Directive 98/79/EEC on IVD medical devices is an acknowledgment of the rigor and quality processes followed by Gestalt,” says Roopam Kakoti, Vice President, Product Engineering at Gestalt.
The CE-IVD mark for PathFlow provides our customers with the security and knowledge that our solutions are developed to the highest standards for safety and effectiveness. In addition, our solutions are developed in collaboration with our esteemed advisory board of pathologists to ensure the best features, functionality and usability in support of industry-leading clinical workflows. PathFlow is designed for pathologists by pathologists.
“A truly interoperable platform that integrates all the components needed to streamline pathologist workflow is essential to realizing the full benefits of digital pathology,” said Lisa Jean Clifford, COO & Chief Strategy Officer at Gestalt. “Achieving these CE-IVD marks is an important milestone for our company in providing assurance that our solutions meet the regulatory standards required for patient care while increasing the speed and efficiency of their providers.”
Gestalt Diagnostics, Inc.
Gestalt transforms pathology with an intelligent, configurable, vendor-neutral digital workflow that provides true interoperability for pathologists to diagnose* diseases faster and more effectively. Our journey® solution is a cloud-based digital pathology enterprise platform that can easily be customized to your specific preferences. This platform consists of professional, educational and research modules to make it easy to mix and match your institution’s digital needs in a single solution, freeing pathologists from tedious, repetitive and manual tasks allowing them to focus on their expertise, offering their invaluable experience where it matters most. Learn more about www.gestaltdiagnostics.com or follow the Gestalt on LinkedIn and Twitter.
*Research Use Only (RUO) unless following CAP guidelines for LDT.