Epredia, a subsidiary of PHC Holdings, has received US Food and Drug Administration (FDA) 510(K) approval for its E1000 Dx Digital Pathology Solution.
E1000 Dx is a high-speed, automated whole-slide imaging digital scanner that includes a medical-grade viewer and advanced image management software.
The scanner produces high-resolution images of up to 1,500 tissue samples daily.
E1000 Dx aims to enhance laboratory throughput and streamline cancer diagnostics, addressing the increasing demand for cost-effective pathology solutions.
With FDA clearance, Epredia expands its digital pathology technology portfolio, potentially improving diagnostic accuracy and efficiency amidst rising cancer cases.
Epredia chief strategy officer Balazs Liposits said: “Digital pathology is the future of cancer diagnostics, but adoption has historically meant laboratories piecing together various hardware and software, which has caused challenges with interoperability.
“At Epredia, we provide precision equipment that covers the total workflow of the laboratory from accessioning to sign out.
“We launched the E1000 Dx to meet the needs of laboratories for throughput and quality, while also maintaining interoperability to help facilities maximise their digital pathology investment and minimise time needed from healthcare professionals.”
The E1000 Dx features algorithm-based sample detection to advance scanning by pinpointing sample locations, and dual slide processing to boost workflow efficiency by processing two slides simultaneously.
It is the first FDA-approved digital pathology solution with a quality control feature that triggers an advanced focal map rescan to ensure high image quality, said the company.
Also, it is interoperable with existing laboratory equipment and software.
Epredia has offered the technology behind the E1000 Dx in the US for research use and as an IVD instrument in Europe since 2017.
The company has refined the device to address higher clinical quality standards, providing a simple workflow for laboratories.
Epredia is manufacturing E1000 Dx scanners at its facility in Runcorn, UK, and plans to commercialise the digital scanner to the clinical facilities in the US.
