Sectra (STO:SECTB) and Leica Biosystems announced that they formed a partnership to collaborate in an effort to win FDA clearance for an integrated clinical pathology solution.
The companies said their goal is to address the clinical needs of enterprise-level customers, including academic medical centers, clinical research organizations and large hospital networks. They have already submitted an application for FDA 510(k) clearance.
Sectra’s digital pathology software solution is designed to facilitate streamlined image access, review and diagnosis while allowing for integration with pathology information systems and electronic medical records.
Leica Biosystems’ Aperio AT2 DX system is an automated digital scanner designed to deliver diagnostic-quality whole slide images with high confidence. The companies believe that integrating the two platforms will give clinical organizations a way to deliver a unified solution for improved patient care and financial outcomes.
“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, enable us to deliver a clinical solution to meet the needs of the truly integrated digital hospitals of today and tomorrow,” Sectra founder & CEO Torbjörn Kronander said in a news release. “This is an exciting and important advancement for the clinical pathology industry and a huge step forward in clinical usability.”
“This is an important step towards improving patient care with digital technology,” added Leica Biosytems global VP of advanced staining and imaging Colin White. “We look forward to working with Sectra to offer streamlined digital pathology solutions for clinical organizations.”
Original Article: (https://www.massdevice.com/sectra-and-leica-seek-fda-clearance-for-digital-pathology-solution/)