NEW YORK – Precision cancer diagnostics firm Epredia said on Tuesday that it has received US Food and Drug Administration 510(k) marketing clearance for a whole-slide imaging system that is used for the creation, viewing, and management of surgical pathology slide images.
The company's E1000 Dx Digital Pathology Solution consists of an automated high-speed scanner, whole-slide image viewer, and image management and viewing software. The firm said that the system can be used for the creation of high-resolution images of up to 1,500 tissue samples daily, adding it is designed to maximize laboratory throughput and efficiency through algorithm-based sample detection that allows for quicker scanning, the simultaneous processing of two slides, and a quality control feature that provides automatic rescanning. The system is also designed for interoperability with laboratory equipment and software from other firms.
"We launched the E1000 Dx to meet the needs of laboratories for throughput and quality, while also maintaining interoperability to help facilities maximize their digital pathology investment and minimize time needed from healthcare professionals," Epredia Chief Strategy Officer Balazs Liposits said a statement.
Epredia, which is the precision cancer diagnostics business of PHC Holdings, said a year ago that it had been working to expand its menu of instruments that are used in sample processing workflows and developing partnerships on the use of image analysis software with the firm's scanners.