FDA clearance—Sectra’s digital pathology solution available for primary diagnostics and remote reading in the U.S.
Linköping, Sweden and Shelton, CT – April 1, 2020 – International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has received a 510(k) clearance by the US Food & Drug Administration (FDA). The clearance applies for Sectra Digital Pathology Module, the key component of Sectra’s pathology solution, when used together with Leica Biosystems’ scanner AT2 DX. This enables US healthcare providers to use Sectra’s digital pathology solution for primary diagnostics. The solution makes it possible to move towards fully integrated diagnostics, which is especially