NEW YORK — Sectra said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its Sectra Digital Pathology Module for use in primary diagnostics.
The module, which is already available in the US for research and tumor boards, provides access to current and historical digital images of tissue samples, related data, and tools for image review. With the clearance, it can now be used for primary diagnosis in combination with Leica Biosystems' AT2 DX high-throughput automated scanning and viewing platform, which received FDA clearance last year.
Linköping, Sweden-based Sectra and Leica began working together on an integrated clinical pathology solution in late 2019.
"We are now able to offer US healthcare providers a digital pathology offering with a proven track-record of use for full-scale primary diagnostics and large volumes," Mikael Anden, president of Sectra's US operations, said in a statement. "Our solution makes it possible for pathologists across the country to continue their important work from home without the need for a microscope."