Leica Biosystems and Sectra Partner to Pursue FDA Clearance for an Integrated Clinical Digital Pathology Solution
VISTA, CA –December 2nd, 2019 – Leica Biosystems, the global leader in pathology workflow solutions, and the international medical imaging IT and cybersecurity company, Sectra, announce a collaboration to seek a combined 510(k) clearance from the U.S. Food & Drug Administration (FDA) in the near future. The goal is for the integrated clinical digital pathology solution to address the clinical needs of enterprise level customers such as academic medical centers, clinical research organizations and large hospital networks.
“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, would enable us to deliver a clinical solution to meet the needs of the truly integrated digital hospitals of today and tomorrow,” said Torbjörn Kronander, Founder & CEO of Sectra. “This will be an exciting and important advancement for the clinical pathology industry and a huge step forward in clinical usability.”
The Sectra digital pathology software solution, a component of the enterprise imaging offering, will facilitate streamlined image access, review, and diagnosis, as well as deep integration with leading Pathology information systems and EMRs. Leica Biosystems Aperio AT2 DX system is a high-throughput automated digital scanner that delivers diagnostic-quality whole slide images with high confidence. The integration of these two solid platforms would 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 and hardware solutions. Moreover, Leica Biosystems recognizes the need for a wide variety of use cases and applications which simply cannot be addressed by a single provider. Leica Biosystems open platform would enable customers to choose their preferred workflow solutions.
“This is an important step towards improving patient care with digital technology,” said Colin White, Global Vice President of Leica Biosystems Advanced Staining & Imaging Business. “We look forward to working with Sectra to offer streamlined digital pathology solutions for clinical organizations.”
The clinical use claims described for Primary Diagnosis have not been cleared or approved by the U.S. FDA. Any future capabilities will require FDA clearance before diagnostic use.
About Leica Biosystems
Leica Biosystems (LeicaBiosystems.com) is a cancer diagnostics company and a global leader in workflow solutions, offering the most comprehensive portfolio from biopsy to diagnosis. With unique expertise, we are dedicated to driving innovations that connect people across radiology, pathology, surgery and oncology. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is headquartered in Germany and operates in over 100 countries.
About Sectra Imaging IT Solutions
With more than 25 years of innovation and 1,800 installations, Sectra is a leading global provider of imaging IT solutions that support healthcare in achieving patient-centric care. Sectra offers an enterprise imaging solution comprising PACS for imaging-intense departments (radiology, pathology, cardiology, orthopedics), VNA, and share and collaborate solutions. Read more about Sectra and why Sectra PACS is “Best in KLAS” for a sixth consecutive year at http://www.sectra.com/medical/.