Sectra and Leica Biosystems partner to pursue FDA clearance for an integrated clinical digital pathology solution
Linköping, Sweden and Shelton, CT – December 2, 2019 – International medical imaging IT and cybersecurity company Sectra (STO: SECT B) and Leica Biosystems announce collaboration for an integrated clinical pathology solution. The goal is to address the clinical needs of enterprise level customers such as academic medical centers, clinical research organizations and large hospital networks. A 510(k) application for the combined solution has been submitted to the U.S. Food & Drug Administration (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, enable us to deliver a clinical solution to meet the needs of the truly integrated digital hospitals of today and tomorrow,” says Torbjörn Kronander, Founder & CEO of Sectra. “This is 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 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 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 will enable customers to choose their preferred workflow solutions.
“This is an important step towards improving patient care with digital technology,” says 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 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/.
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, Leica Biosystems is dedicated to driving innovations that connect people across radiology, pathology, surgery and oncology. The mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of the corporate culture. The 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.
For further information, please contact:
Dr. Torbjörn Kronander, CEO and President Sectra AB, +46 (0)705 23 52 27
Marie Ekström Trägårdh, Executive Vice President Sectra AB and President Sectra Imaging IT Solutions, +46 (0)708 23 56 10
Sectra assists hospitals throughout the world to enhance the efficiency of care, and authorities and defense forces in Europe to protect society’s most sensitive information. Thereby, Sectra contributes to a healthier and safer society. The company was founded in 1978, has its head office in Linköping, Sweden, with direct sales in 19 countries, and operates through partners worldwide. Sales in the 2018/2019 fiscal year totaled SEK 1,413 million. The Sectra share is quoted on the Nasdaq Stockholm exchange. For more information, visit https://sectra.com/.