Sectra, Linköping, Sweden, and Leica Biosystems, Shelton, Conn, have collaborated to develop an integrated digital pathology solution that will address the needs of enterprise-level clinical customers such as academic medical centers, clinical research organizations, and large hospital networks. A premarket notification (510(k)) application for the combined solution has been submitted to FDA.
“Leveraging Leica Biosystems’ existing 510(k) clearance for its Aperio AT2 DX scanner, and extending it with the Sectra digital pathology solution for hospitals and health systems, enables us to deliver a clinical solution to meet the needs of the truly integrated digital hospitals of today and tomorrow,” says Torbjörn Kronander, founder and CEO of Sectra. “This is an exciting and important advancement for the clinical pathology industry and a huge step forward in clinical usability.”
As a component of the enterprise imaging offering, the Sectra digital pathology software solution will facilitate streamlined image access, review, and diagnosis, as well as deep integration with leading pathology information systems and electronic medical records. Leica Biosystems’ Aperio AT2 DX system is a high-throughput automated digital scanner that provides diagnostic-quality whole-slide images with high confidence. Integration of the two platforms will enable clinical organizations to deliver a scalable, unified solution for optimized patient care and financial outcomes.
Leica Biosystems is committed to investing in the development of Aperio digital pathology software, image analysis systems, and hardware. Moreover, the company recognizes the need for a wide variety of use cases and applications that cannot be addressed by a single provider. Leica Biosystems’ open platform will enable customers to choose their preferred workflow solutions.
“This is an important step toward improving patient care with digital technology,” says Colin White, global vice president of Leica Biosystems’ advanced staining and imaging business. “We look forward to working with Sectra to offer streamlined digital pathology solutions for clinical organizations.”
Clinical use claims described for primary diagnosis have not been cleared or approved by FDA. Any future capabilities will require FDA clearance before diagnostic use. For more information, visit Sectra and Leica Biosystems.