Epredia has received clearance from the U.S. Food and Drug Administration (FDA) for its E1000 Dx Digital Pathology Solution (E1000 Dx).
This 510(k) clearance allows the technology to be used clinically in the United States.
The E1000 Dx is a high-speed, automated digital scanner designed for whole-slide imaging. It includes a medical-grade viewer and advanced image management software to produce high-resolution digital images of up to 1,500 tissue samples per day.
By enabling laboratories to increase efficiency, the system aims to support faster and more streamlined cancer diagnostics.
The growing incidence of cancer has increased pressure on pathology laboratories to improve speed and reduce costs. The E1000 Dx is developed to enhance laboratory productivity with advanced features in sample detection and quality control.
One key improvement is an algorithm-based detection system that accurately identifies sample locations, allowing quicker scanning. The system also supports dual slide processing, improving workflow efficiency by scanning two slides at the same time.
Additionally, it is the first FDA-cleared digital pathology solution to incorporate a quality control mechanism that can trigger an advanced focal map rescan if needed, ensuring high image quality for pathologists’ review. The E1000 Dx is also designed to integrate smoothly with other laboratory equipment and software.
Epredia has offered this technology for research purposes in the United States and as an in vitro diagnostic (IVD) instrument in Europe. The E1000 Dx has now been refined to meet the stricter requirements for clinical use, aiming to offer a more efficient workflow for laboratory professionals.
With FDA clearance, Epredia will introduce the technology to clinical facilities across the United States, expanding its application from research to patient care.
