The PathFlow Viewer and Automated Workflow now have European regulatory clearance for use in education, clinical, and research laboratories
Gestalt Diagnostics has secured two CE-IVD marks for its PathFlow digital pathology solution. (Credit: Gerd Altmann from Pixabay)
Gestalt Diagnostics has secured CE-IVD marks for PathFlow Viewer and the Automated Workflow components of its digital pathology solution PathFlow.
According to the digital pathology solutions provider, the European regulatory clearance will enable PathFlow’s wider use in education, clinical, and research laboratories.
The PathFlow platform is said to be a cloud-based digital pathology enterprise platform that can be customised easily for individual requirements.
Gestalt Diagnostics said that the platform consists of professional, educational, and research modules for ease of mixing as well as matching the digital requirements of a facility in a single solution. It reduces mundane, repetitive, and manual tasks and allows pathologists to focus on their expertise.
The European regulatory clearance will allow healthcare facilities to fully deploy the PathFlow Viewer and the Automated Workflow components and recognise the value of digital pathology throughout their organisations, the pathology solutions provider claimed.
Gestalt Diagnostics said that pathologists or researchers can use the viewer to retrieve all the data associated with their study, case, or course in a single process and it remains the same across all PathFlow modules.
Gestalt Diagnostics product engineering VP Roopam Kakoti said: “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.”
The firm said that the CE-IVD designation for PathFlow shows that the solutions were created in accordance with the highest requirements for efficacy and safety.
Gestalt Diagnostics COO and chief strategy officer Lisa-Jean Clifford said: “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.
“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 Diagnostics claimed that its digital pathology solutions are developed together with its advisory board of pathologists to ensure the optimum usability, features, and functionality in support of clinical workflows in the industry.