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


PathFlow® Viewer and Automated Workflow Now European Regulatory Cleared for Use in Primary Diagnosis*

SPOKANE, Wash., Oct. 9, 2022 /PRNewswire/ — 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.


Gestalt Diagnostics (PRNewsfoto/Gestalt Diagnostics)

PathFlow® Viewer and Automated Workflow Now European Regulatory Cleared for Use in Primary Diagnosis*.

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.”

Explore the PathFlow Ecosystem at CAP 22 in New Orleans, Oct 8-10.

Gestalt Diagnostics, Inc.

Gestalt transforms pathology through an intelligent, configurable, and vendor-neutral digital workflow that provides true interoperability enabling pathologists to diagnose* diseases faster and more efficiently. Our PathFlow® solution is a cloud-based digital pathology enterprise platform that can easily be customized based on your specific preferences. This platform consists of professional, education, and research modules for ease of mixing and matching the digital needs of your facility in a single solution, freeing pathologists from tedious, repetitive, and manual tasks allowing them to focus on their expertise, providing their invaluable experience where it matters most. Learn more at www.gestaltdiagnostics.com or follow Gestalt on LinkedIn and Twitter.

*Research Use Only (RUO) unless following CAP guidelines for LDT.

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SOURCE Gestalt Diagnostics

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