PathFlow viewer and automated workflow are now European regulatory cleared for use in primary diagnosis.
Gestalt Diagnostics 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 organisations. 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 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.
"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 and 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."
Gestalt’s PathFlow solution is a cloud-based digital pathology enterprise platform that can easily be customised based on 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.
Learn more at www.gestaltdiagnostics.com.
