Gestalt's Digital Pathology Solution Receives Two CE-IVD Marks

Tuesday, October 11, 2022

Gestalt Diagnostics, Inc., a leading provider of award-winning digital pathology solutions, announced today that it has received CE-IVD marks for two of the main components of PathFlow. Both the PathFlow viewer and the proprietary, automated workflows now have European regulatory clearance for broad use in clinical, education, and research laboratories.

The European regulatory certification of these key components of Gestalt's PathFlow provide the support some healthcare facilities need to fully deploy and recognize the value of digital pathology throughout their organizations. Gestalt's feature-rich viewer is consistent throughout all the PathFlow modules whether clinical, education, or research and provides the pathologist or scientist with access to all of the information related to their case, study, or course in a single, streamlined environment.

"The award of CE mark for PathFlow's Viewer and Pathologist Workflow application per IVD Medical Device Directive 98/79/EEC is in recognition of the rigor and quality processes Gestalt follows," says Roopam Kakoti, VP, Product Engineering at Gestalt.

CE-IVD mark for PathFlow provides our customers with the security and knowledge that our solutions are developed with the highest standards for safety and efficacy. In addition, our solutions are developed in conjunction with our esteemed advisory board of pathologists to ensure the best features, functionality, and usability in support of clinical workflows in the industry. PathFlow is made for pathologists by pathologists.

"A truly interoperable platform which incorporates every component necessary to streamline the workflow for pathologists is essential for leveraging the full benefits of digital pathology," said Lisa-Jean Clifford, COO & Chief Strategy Officer at Gestalt. "The receipt of these CE-IVD marks is an important milestone for our company in providing the assurance that our solutions meet the regulatory standards required for patient care while increasing speed and efficiency for their providers."

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